Medication Errors: The Problem and Its Scope Nancy B. Carothers, RN, BA Editor's Note: This is the first of a series that will discuss medication errors from the point of view of collecting information, looking at processes and systems, and prevention measures, The information is based on the US Pharmacopeia's (USP) Education Resource,
Understanding and Preventing Medication Errors 1 and from reports received through the USP Medication Errors Reporting (MER) Program.
ABOUT THE US PHARMACOPEIA (USP) he rich tradition of the USP began in the early 1800s, when a physician, Lyman Spalding, recognized the need for drug standardization. At that time, drug names and formulations differed from region to region and from physician to physician. In response to these variations in quality, purity, and potency of medicines, Spalding and 10 fellow physicians founded the United States Pharmacopeia in January of 1820. Over the next year, they created the pharmacopeia, which listed standard drug names and drug formulas (phar.ma.co.pei.a: preparation of drugs, derived from [Greek] pharmakon, drug + poiein, to make; A book comainmg an official or standard list of drugs along with recommended procedures for their preparation and use. 2) By December of 1820, the first Pharmacopoeia of the United States of America 3 was published. Today, USP continues to provide standards for drug formulas, packaging, labeling, inactive ingredients (excipients), nomenclature, and storage. The standards are enforced by the Food and Drug Administration (FDA) and ensure the quality, punty, and required potency for all medicines available
in the United States. Throughout the world, many countries ensure the quality of their medicines by adopting USP drug standards. Since 1970, USP has provided authoritative, clinically relevant, evidence-based drug information for health care professionals, patients, and consumers. This information is provided to health care professionals and patients (in easy-to-read leaflets and in Spanish) and covers both approved and unapproved uses for medicines. The unapproved (sometimes called "off label") uses are those not included in the original drug research and development process. For example, some cancer protocols require combinations of chemotherapy drugs--where each drug was approved, but not their use together. Many USP educational materials for health care professionals and patients are available at USP's Website: http://www.usp.org.
UNDERSTANDING AND PREVENTING MEDICATION ERRORS Medication errors not only cause harm to patients, they also mar the reputation of all health care professionals in whom patients place their trust.
Medication errors not only cause harm to patients, they also mar the reputation of all health care professionals in whom patients place their trust.
From the US Pharmacopeia. For reprints, or more information concerning the USP, contact Nancy B. Carothers, RN, BA, Health Communications Specialist, Office of External Affairs, The United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852. Int J Trauma Nurs 1998;4:104-8. 1075-4210/98/$5.00 + 0 6511190838 104
INTERNATIONAL JOURNAL OF TRAUMA NURSING/USP
What Is a Medication Error? The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) represents 16 of the nation's leading health care and consumer organizations (Table 1). It was established because its members recognized that the involvement of all health care system particiVOLUME 4, NUMBER 3
Table 1. National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) American Association of Retired Persons American Health Care Association American Hospital Association American Medical Association American Nurses Association American Pharmaceutical Association American Society of Consultant Pharmacists American Society of Health-System Pharmacists American Society for Healthcare Risk Management Food and Drug Administration Generic Pharmaceutical Industry Association Joint Commission on the Accreditation of Healthcare Organizations National Association of Boards of Pharmacy National Council of State Boards of Nursing Pharmaceutical Research and Manufacturers of America United States Pharmacopeia
Table 2. Scope of the problem • Physician with illegible handwriting • Pharmacist who dispenses a drug with a name similar to the drug actually ordered • Nurse who misreads similar looking packaging and administers an incorrect injection • Pharmacy technician who mislabels an infusion • Caregiver who puts ear drops in the eyes • Patient who thinks "more is better"
pants is needed to correct medication errors. Members represent the practitioners, pharmaceutical product manufacturers, standards providers, regulators, risk managers, patients, caregivers, and consumers. The NCC MERP definition of a medication error is as follows: "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. Such events may be related to professional practice, health care products, procedures, and systems including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use." JULY-SEPTEMBER 1998
S c o p e of t h e P r o b l e m
Experience shows that anyone on the health care team can make a medication error, and that such errors are virtually always unintentional (Table 2). A 1995 study identified 247 adverse drug events, of which 70 (28%) were due to errors. Most of the errors occurred at the physician-ordering (39%) and nurse-administration (38%) stages. The remaining errors were divided between the transcription and pharmacy dispensing stages. 4 Medication administration errors, which were measured from a series of studies over 25 years (and excluded wrong-time errors), suggested that the frequency rate had been approximately one per patient per day. With the change to unit dose distribution systems, the error rates have been reduced to two or three per patient per week. 5 Fortunately, most errors are caught before they cause injury to the patient, and, for this reason, most go unreported. But it is just as important to identify and report potential errors (and the related system failures) as it is to report actual errors. Nurses can play a key role in solving medicationerror problems by participating in and reporting to a nationwide system that tracks and monitors errors. The experience learned from confidential reports are then shared with the health care community to better educate practitioners concerning medication-error prevention.
it is just as important to identify and report potential errors . . . as it is to report actual errors. •
.
.
HOW M e d i c a t i o n Errors O c c u r
As a medication order travels through its many communication stages, the opportunities for error increase. Medication errors occur as a result of (1) knowledge and/or (2) performance deficits. It is similar to the child's game of telephone (or "pass it on") where a word or short sentence is whispered into a player's ear, then whispered to the next person, and so on, until the last player announces the word or sentence that usually has changed to an unrecognizable word or phrase. In the game of telephone knowledge and performance deficits conceming the meaning, pronunciation, or word order occur. Unfortunately, medication errors often occur INTERNATIONAL JOURNAL OF TRAUMA NURSING/USP 105
Table 3. Questions to ask to prevent medication errors
Prescribing: (1) Do the patient's symptoms fit the physician's order? (2) Is the prescription recorded correctly in the medical record?
Documenting: (1) Has the staff accurately transcribed the physician's verbal or written order into the medication administration record? (2) Has the transcription been sent to the pharmacist in a timely manner (verbal, written, or by phone)? (3) Has the pharmacist entered the medicine order into the patient's computer profile and checked for potential drug interactions?
Dispensing: (1) Has the pharmacy technician prepared the medicine properly? (2) Has the pharmacist checked the medicine against the order? (3) Was the medicine sent to the patient's unit on time?
Administering: Has a knowledgeable practitioner administered the drug: (1) Via the correct route? (2) In the ordered amount? (3) At the specified time?
Monitoring: (1) Was the drug actually taken or infused? (2) Were there any adverse drug effects or reactions? (3) Did the drug improve the patient's condition?
because of knowledge and performance deficits related to the communication process. For example, a physician hurriedly writes (performance) a medication order for Lodine 300 mg. A nurse, who is unfamiliar with the drug (knowledge), misreads the illegible handwriting (performance) and requests codeine 30 mg from the pharmacy. If the pharmacist has reviewed the patient's profile (knowledge) and has had a patient consultation (performance), then the medication error can be corrected before reaching the patient. The practitioner must question the appropriateness and accuracy of every action taken during the entire process of prescribing, documenting, dispensing, administering, and monitoring medicines. Table 3 lists common questions to ask at each step in the process. In trauma nursing, the stages in the continuum can move very rapidly, and there may 106 INTERNATIONALJOURNAL OFTRAUMA NURSING/USP
Table 4. Types of system failures that lead to medication errors 5 Drug knowledge dissemination Dose and drug name checking Patient information availability Order transcriptions Allergy defense Medication order tracking Interservice communication Device use Standardization of doses and frequencies Standardization of drug distribution within unit Standardization of procedures Preparation of medication Transfer/transition problems Staffing and work assignments Feedback about adverse drug events
Medicines with similar names or packaging... should be stored in separate areas of the drug supply cabinet.
not be time to correct knowledge or performance deficits. The practitioner may not have the time or opportunity to check a drug reference or obtain a full medical and treatment history. Medication errors can be decreased in emergency situations by planning ahead for the rapid, but safe, retrieval of medicines. Medicines with similar names or packaging, or known to be easily misidentified, should be stored in separate areas of the drug supply cabinet. If specific, predetermined routines are followed by an emergency department, such as a clinical pathway for chest trauma, then any deviations from the "drug" pathway should be explained, approved, and noted by the appropriate members of the health care team. Medication orders calling for deviations from the "usual" amounts of a medicine, or orders requiring unusually large amounts of a drug product, should be questioned and verified. It should be standard practice to repeat verbal orders back to the person ordering medicines to verify that "what was heard" was the actual order. VOLUME 4, NUMBER 3
Table 5. Reports from the USP Practitioners' Reporting Network Operating Room: (1) A toddler received mivacurium instead of Marcaine. The drug was injected into the caudal epidural space to relieve postoperative pain following minor testicular surgery. The mivacurium had been prepared by the anesthesiologist for a prior patient but had not been used. A resident picked up the wrong syringe, and it was handed to the anesthesiologist for injection. (2) Twelve premixed bags of mivacurium were found in a surgical area employee break room. No one knew why the medicines were there and, later, several dozen more bags were recovered from the ambulatory surgery area. It was thought that the bags were left by a sales representative and approximately a dozen more bags could not be accounted for. Considering the potentially lethal nature of these products, this must be viewed as a dangerous activity that could lead to serious medication errors. Intensive Care Unit: (1) Medical resident gave vecuronium bromide to treat anxiety secondary to the insertion of an intravenous infusion and did not realize the patient was not intubated. (2) Nurse gave pancuronium bromide instead of a heparin flush, which put the patient on a respirator for 10 hours. (3) Nurse gave patient, coming off of a ventilator, vecuronium bromide (which had been in use for ventilator control) instead of potassium chloride. Patient remained on ventilator 6 hours longer than planned. Emergency Department: (1) Nurse mistakenly took pancuronium bromide (Pavulon) from the emergency department refrigerator instead of flu vaccine, which was packaged in a "look alike" vial and gave the drug to six patients. (2) The antibiotic, cefazolin sodium (Ancef) 500 mg was ordered for a pediatric patient, and the mnemonic "anec 500" was used instead of "ance 500." Several doses of a neuromuscular blocker, succinylcholine chloride (Anectine) 500 mg, were sent to the unit instead of the antibiotic. Because the nurse questioned the physician about the drug and the large volume, the error was prevented. The mnemonic "anec 500" was changed to "SUCC 500."
P r e v e n t i n g M e d i c a t i o n Errors
If medication errors are to be prevented, the
processes and systems for ordering, dispensing, and administering medicines must be analyzed. The goal is to reduce knowledge and performance deficits and to redesign and improve staff communications. A recent court case, 6 in which nurses were charged with negligent homicide because of a medication error that resulted in the death of a newborn, shows a dangerous change in public opinion. More and more, such errors may be viewed as criminal rather than civil wrongs. In this climate, all health care professionals must demonstrate that they have made every logical effort to reduce knowledge or performance deficits and to remove any impediments to accurate communication processes. Professional nurses have the expertise to assess the interactions of health care team members throughout all stages of drug delivery. Nurses should not assume that the problems of medication mix-ups will be considered some other service's responsibility. Medication-error prevention begins when the problem is recognized as a system failure (not an individual failure), and when the work enviJULY-SEPTEMBER 1998
A medical care facility that encourages full reporting of all medication errors.., allows an honest exchange of information that can be used to prevent future e r r o r s . . .
ronment provides and encourages safe, confidential reporting of errors without retribution. R e p o r t i n g M e d i c a t i o n Errors
Intra-facility. A medical care facility that encourages full reporting of all medication errors, whether actual or potential, allows an honest exchange of information that can be used to prevent future errors in any part of the facility's medication process (continuum). It is through this reporting process that "system" errors can be found before medication errors occur. For example, medicines put in unlabeled medicine cups on a sterile INTERNATIONAL JOURNAL OF TRAUMA NURSING/USP 107
field, or left in unlabeled syringes on an anesthesia cart, or medicines added to inadequately labeled intravenous containers, may indicate a break in the standardization of safe procedures or medication preparation (Table 4). When an "efficiency" measure, such as making up unlabeled prefilled syringes compromises safety, the measure must be analyzed and changed. Nationally. Participation in error-prevention programs such as USP's Practitioner Reporting Network (USP PRN) helps health care. facilities individually and collectively by identifying c o m m o n p a t t e r n s of medication errors. If the information is not shared, some medication errors could be interpreted as isolated incidents and go unnoticed. By identifying a medication-error pattern, strategies can be created to prevent future errors. USP PRN has collected information related to problems with medicines and medical devices for more than 26 years. There are four separate reporting programs: the Drug Product Problem Reporting (DPPR) program, the Medication Errors Reporting (MER) program, the Drug Product Problem Reporting Program for Radiopharmaceuticals, and the Veterinary Practitioners' Reporting program. 1 On the national level, the collection of information and the collaboration among health care groups can lead to resolutions such as changing labding information, maintaining proper drug storage temperatures, ensuring accurate prescription writing, and improving storage and shipping measures. USP's promotion of the importance of sharing experiential data collected from health care professionals through its nationwide reporting system has resulted in more than 100,000 observations and suggestions to the DPPR program. This effort enables the DPPR to track, analyze, and compare drug product problems throughout the United States. The MER program encompasses a wide variety of medication-error causes such as miscalculations, misadministrations, and misinterpretation or misunderstanding of written or verbal orders.t The collection of thig confidential informa-
108
INTERNATIONAL JOURNAL OF TRAUMA NURSING/USP
tion alerts the USP, industry, and the appropriate government agencies about problems or potential problems related to medicines. Table 5 lists actual incidents reported to the USP Practitioners' ReportingNetwork. Reports may be submitted by mail, by fax (301/816-8532), by telephone (800/487-7776), or through the Internet (http://www.usp.org/prn).
SUMMARY Nurses can take an important lead role in protecting their patients, their peers, and themselves from the unfortunate consequences of medication errors. Medication errors occur for a variety of reasons, including inaccurate communications and deficits in knowledge and performance by and among all health care professionals. These problems and deficits need to be addressed. USP stresses the importance of focusing on the process or system in which the error occurred, rather than focusing blame on an individual. By acknowledging all actual and potential errors, and by consistently assessing and reassessing systems, nurses can help reduce medication errors and contribute significantly to improved patient safety. REFERENCES 1. Aschenbrenner D, Boesen M, Cohen MR, Davis NM, Esser L, Felver L, et al. Understanding and preventing medication errors: an education resource. Rockville (MD): United States Pharmacopeia; 1996. 2. Office of External Affairs. Promoting the public health. Rockville (MD): United States Pharmacopeia; 1995. 3. Anderson L, Higby G, The spirit of voluntarism: a legacy of commitment and contribution. The United States Pharmacopeia 1820 to 1995. Rockville (MD): United States Pharmacopeia; 1995. 4. Leape LL, Bates DW, Cullen DJ, Cooper J, Demonaco HJ, Gallivan T, et al. Systems analysis of adverse drug events: ADE Prevention Study Group. JAMA 1995;274:35-43. 5. Allan EL, Barker KN. Fundamentals of medication error research. Am J Hosp Pharm 1990;47:555-71. 6. Cohen MR. IV drug safety: the real error: blaming people, not the process. INS Newsletter 1997;18:3.
VOLUME 4, NUMBER 3