Medication Safety: Patient Safety Focus A Knowledge Based Course. Jeff Blackburn, C.Ph.T., MBA Healthcare Administration

Transcription

1 The Texas Tech University HSC- School of Pharmacy is accredited by The Accreditation Council For Pharmaceutical Education (ACPE) as a provider of continuing Pharmaceutical Education. Course Administered By: J&D Educational Services, Inc PO Box The Woodlands, Texas Voice: Fax: Medication Safety: Patient Safety Focus A Knowledge Based Course By Jeff Blackburn, C.Ph.T., MBA Healthcare Administration ACPE No H05-T Release Date: 03/18/2013 Expiration Date: 03/18/2016 Total number of pharmacy continuing education hours: 2 hours (0.2 CEU s) Course Cost: Average time to Complete: Course Value: Reading: Final Exam: Completion Requirements: $9.00 (to be paid at time of testing) Approximately two hours including testing Two Contact Hours 25 Pages 25 Questions Answer 70% of questions correctly, Evaluation

2 OBJECTIVES 1. Identify the potential liabilities associated with medication errors. 2. List the most common types of medication errors and how they can be prevented. 3. Describe how to manage and prevent medication errors in your particular type of pharmacy practice. Table Of Contents CHAPTER 1 CHAPTER 2 CHAPTER 3 CHAPTER 4 INTRODUCTION MEDICATION ERRORS: DESCRIPTION AND PREVENTION TECHNIQUES CAUSES OF MEDICATION ERRORS YOU GAVE ME THE WRONG DRUG 2

3 CHAPTER 1 INTRODUCTION When thinking about treating a patient, the adage first do no harm is appropriate. In a society where people think there is a pill for every problem, it is difficult, if not downright impossible, to remain current on the potentially deleterious affects of medications and their various combinations. Before 1962, the topic of medication errors was NOT discussed. Barker and McConnel became the first to show that medication errors occurred at a rate of 16 per 100 doses in Today, it is not unusual to see an article in the newspaper, or hear about another Healthcare Misadventure in the news. The problem has become a focus of concern for all healthcare accrediting agencies. The public was shocked about fatal medication errors at Dana Farber Cancer Institute in Boston in The knowledgeable health reporter for the Boston Globe, Betsy Lehman, died from cardiotoxicity due to a drug overdose. Other shocking headlines include one about a man having the wrong leg amputated and an eight year old dying during minor surgery due to a drug mix-up. At least 44,000 people and perhaps as many as 98,000 people die in hospitals each year as a result of medical errors that could have been prevented. Types of problems that commonly occur during the course of providing health care include the following: adverse drug events, improper transfusions, surgical injuries, wrong-site surgery, suicides, restraint related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities. The country was recently shocked to hear about a fatal blood type error that occurred in a young patient during a heart and lung transplant at Duke University Medical Center in Preventable medical errors in hospitals exceed the number of deaths attributable to such feared threats as motor-vehicle accidents, breast cancer, and AIDS. In 1997, three nurses were charged with criminally negligent homicide for a medication error that involved an infant who was given a ten-fold overdose by the wrong route of penicillin. In July 2001, additional patient safety standards went into effect by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). These standards address a number of significant patient safety issues which include the following: 1. The responsibility of organization leadership to create a culture of safety. 2. The implementation of patient safety programs. 3. The response to adverse events when they occur. 4. The prevention of accidental harm through the prospective analysis and re-design of vulnerable patient systems (e.g. the ordering, preparation and dispensing of medications). 5. The healthcare organization s responsibility to tell a patient about the outcomes of the care provided to the patient, whether good or bad. The significance of this medication error problem is demonstrated by President Bush s proposal for $10 million in new federal funding for projects aimed at reducing medical errors in his 2003 budget plan. The Agency for Healthcare Research and Quality (AHRQ), which already has a $60 3

4 million budget for patient-safety efforts, would get an additional $5 million for grants to help providers adopt proven but underused technologies and to train patient-safety experts. The other $5 million would go to the Food and Drug Administration for responding to and following up on reports of injuries or deaths resulting from FDA-regulated drugs or technology. The money would bring the FDA's dedicated patient-safety budget to a total of $22 million. The Institute for Safe Medication Practice (ISMP) is a non-profit organization that works closely with healthcare practitioners and institutions, regulatory agencies, professional organizations and the pharmaceutical industry to provide education about adverse drug events and their prevention. Founded in 1994, ISMP is dedicated to the safe use of medications through improvements in drug distribution, naming, packaging, labeling, and delivery system design. The organization has established a national advisory board of practitioners to assist in problem solving. Another function of this institute is to provide an independent review of medication errors that have been voluntarily submitted by practitioners to a national Medication Errors Reporting Program (MERP) operated by the United States Pharmacopeia (USP). Information from the reports may be used by USP to impact drug standards as well as share the information with the U.S. Food and Drug Administration (FDA) and pharmaceutical companies whose products are mentioned in the reports. ISMP and the American Hospital Association have a strategic partnership in which ISMP provides leadership and technical expertise in AHA's Prescriptions for Safety initiative. The AHA initiative is to help hospitals identify potential opportunities for improving their facility's medication delivery process. Many other organizations have been formed to attack the problems of medication errors and patient safety. Over the past 10 years, deaths from prescription drug errors increased at a higher rate than any other cause of death except AIDS. The rapid rise in drug-error deaths occurred primarily in outpatients, which included same day surgeries and emergency room visits. There has been a 2.57-fold increase in deaths caused by prescription drug errors from 1983 to Among outpatients, the death rate rose 8.48-fold! In 1983, one of every 539 outpatient deaths was caused by a medication error. The largest number of deaths was caused by errors in dosage or by giving the WRONG drug. In large studies of hospitalized adults, medication errors represent the most frequent cause of injuries from medical care. Roughly 5% of hospitalized adults experience an adverse drug event (ADE), and an additional 5% experience a potential ADE (i.e., the error reached the patient, but no harm occurred). A recent study from an academic children s hospital reported similar rates of ADEs, though rates of potential ADEs were even higher. Most potential ADEs occurred at the stage of drug ordering (79%) and involved incorrect dosing in 34% of these cases. Errors in drug ordering include errors in drug choice (e.g., failure to note an important drug drug interaction or a relevant allergy) and errors in dosing. Related to drug ordering is prescription transcription, as accurately conveying the drug choice or dose are clearly crucial steps in the medication process. Physicians handwritings have become a perennial joke. Although one study suggested that physicians handwritings are no more illegible than that of lawyers and businessmen, physicians handwritings, when illegible, can have life-threatening consequences. 4

5 A study reported in the September issue of Pharmacotherapy in 2001 by Texas Tech University evaluated data from 1116 hospitals. In this report, 913 hospitals reported information on medication errors that adversely affected patient care outcomes. Researchers found that medication errors occurred in 5.07% of admissions, equating to one medication error every 22.7 hours. Medication errors that adversely affected patient care outcomes occurred in 0.25% of all patients admitted to these hospitals/year. Some of the problems associated with medications include the following: 1. One in four people over 65 receive at least one potentially inappropriate drug ,000 people suffer drug-induced Parkinson s symptoms ,000 hip fractures are attributed to prescriptions that leave the elderly sedated or imbalanced ,000 people are hospitalized for ulcers caused by drugs percent of hospitalizations are caused by individuals who experience adverse drug events (ADEs) which translate to 8.8 million hospitalizations every year percent to 30 percent of hospitalized patients experience an adverse drug event. 7. Drug-related problems are the most common adverse event in hospitalized patients ,000 fatalities annually are caused by medication misadventures. 9. Fatalities due to adverse drug reactions are greater than that of high-risk sexual behavior, firearms, and motor-vehicle injuries combined. 10. Medication errors are the second most frequent and the second most expensive malpractice claim. Over $76.6 billion is spent annually on prescription-related drug problems. Considering that the elderly take 40 percent of prescriptions, average 15.4 prescriptions annually, and that the elderly population is growing from one in nine to one in five by the year 2020, these problems show few signs of abating. The most common mistakes include dosing errors (overdosing or under dosing), prescribing medications to which the patient is allergic, and giving duplicate therapy. The drugs involved in most of the errors included antimicrobials (34%), cardiovascular agents (16%), gastrointestinal agents (7%), hormonal agents (4%), and non-narcotic analgesics and nonsteroidal anti-inflammatory agents (5%). The majority of medical errors do not result from individual recklessness or the actions of a particular group, i.e. the bad apple problem. Errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent mistakes. We need to redesign the health system at all levels to make it safer. We need to make it harder for people to do something wrong and easier for them to do it right. The goal of drug therapy is to MAXIMIZE THERAPY OUTCOMES. What we now must do, is not only maximize outcomes, but MINIMIZE RISKS! Bringing state of the art care to every American in every community will require a fundamental, sweeping redesign of the entire health care system. Crossing the Quality Chasm: A New Health System for the 21 st Century, is a report by the Institute of Medicine released in March of 2001 which presents a comprehensive strategy and action plan for the coming decade. This report should be required reading for all health care professionals. 5

6 CHAPTER 2 MEDICATION ERRORS: DESCRIPTION AND PREVENTION TECHNIQUES The National Coordinating Council for Medication Error and Prevention (NCCMERP) defines a medication error as 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. Simply put a medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm. The Institute of Medicine 1999 report To Err is Human defines medical errors as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. The problems and sources of medication errors are multi-disciplinary and multi-factorial. The fragmented nature of the health care delivery system or non-system composed of multiple providers, none of whom has access to complete information has contributed to the epidemic of errors. Errors occur from lack of knowledge, substandard performance and mental lapses, or defects or failures in systems. Medication errors should not be taken lightly and effective systems for ordering, dispensing and administering medications should be established with safeguards to prevent the occurrence of errors. Communication, reasonable workloads, effective drug handling systems, multiple procedural and final product checks by separate individuals, adequate facilities, supplies, equipment, are all important in the prevention of medication errors. The NCCMERP believes that there are no acceptable incidence rates for medication errors. The goal of every health care organization should be to continually improve systems to prevent harm to patients due to medication errors. Health care organizations should monitor actual and potential medication errors that occur within their organization, and investigate the root cause of errors with the goal of identifying ways to improve the medication use system to prevent future errors and potential patient harm. The value of medication error reporting and other data gathering strategies is to provide the information that allows an organization to identify weaknesses in its medication use system and to apply lessons learned to improve the system. The sheer number of error reports is less important than the quality of the information collected in the reports, the health care organization's analysis of the information, and its actions to improve the system to prevent harm to patients. Medication errors include prescribing errors, dispensing errors, medication administration errors, and patient compliance errors. The American Society of Health System Pharmacists has classified types of errors as specified in the following chart. 8

7 TYPE OF MEDICATION ERROR Prescribing error Omission error Wrong time error Unauthorized drug error Improper dose error Wrong dosage-form error Wrong drug-preparation error Wrong administration-technique error Deteriorated drug error Monitoring error DEFINITION Incorrect drug selection based on indications, contraindications, known allergies, existing drug therapy and other factors. Dose, dosage form, quantity, route, concentration, rate of administration, illegible prescriptions, or medication orders that lead to errors that reach the patient. The failure to administer an ordered dose to a patient before the next scheduled dose if any. Administration of medication outside a predefined time interval from its scheduled administration time. (This is established by each healthcare facility). Administration to the patient of medication not prescribed for that patient-wrong drug given to a patient, unordered drugs, doses given outside stated set of clinical guidelines. Administration to the patient of a dose that is greater than or less than the amount ordered by the prescriber or administration of duplicate doses to the patient. Administration to the patient of a drug product in a different dosage form than ordered by the prescriber. Drug product incorrectly formulated or manipulated before administration. Inappropriate procedure or improper technique in administration of a drug. Administration of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised. Failure to review a prescribed regimen for appropriateness and detection of problems, or failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy. Compliance error Other medication error Inappropriate patient behavior regarding adherence to a prescribed medication regimen. Any medication error that does not fall into one of the above categories ASHP GUIDELINES ON PREVENTING MEDICATION ERRORS IN HOSPITALS, Practice Guidelines

8 While most medications have a large margin of safety, a small number of drugs have a high risk of causing injury when they are misused. These medications are called "high alert medications" to draw attention to this characteristic so that all involved in their use will treat them with the care and respect that they require. Errors may or may not be more common with these drugs than with the use of any others. The consequences of errors with these high alert medications may be devastating. For this reason, special considerations are required. These medications often need to be packaged differently, stored differently, prescribed differently, and administered differently than others. Whenever possible, "forcing functions," defined as methods that make it impossible for the drug to be given in a potentially lethal manner, should be developed and instituted. High Alert Medications Adrenergic agonists IV adrenergic antagonists IV magnesium sulfate Sodium chloride injection in > 0.9% concentration Chemotherapeutic agents IV calcium IV digoxin IV potassium (phosphate & chloride) Chloral hydrate, midazolam Opiates Neuromuscular blocking agents High concentration dextrose IV Heparin and oral warfarin, thrombolytics Colchicine injection Insulin Methotrexate tablets Lidocaine/local anesthetics in large vials Topical benzocaine and other local anesthetics Hypotonic sodium chloride Cardioplegic solutions 8

9 It wasn t a stray bullet that killed her it was a stray decimal point. Bridge Medical has been publishing this picture and caption in various medical journals. Their website is Their aim is to not fix blame, but to fix the system. The caption around this picture states that this child died because she was given ten times the required dose of Digoxin. The child died within hours. This is a very sobering advertisement. Everyone should have this picture on their bulletin board in the pharmacy. It really makes you stop and think what can happen if we simply do not take the time to double-check ourselves. The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) has released a document that recommends steps needed to correct error-prone aspects of prescription writing. This organization was formed in 1995 to promote increased awareness, reporting and prevention of medication errors through interdisciplinary cooperation among healthcare providers. This organization issued a set of recommendations aimed at establishing and reinforcing safe prescription writing practices. Fifteen percent of the prescription errors in the United States Pharmacopeia Convention s Medication Error Reporting program database are the result of bad handwriting and misinterpretation of medication orders. Because of this, the NCCMERP has issued the following set of recommendations for prescribers to help prevent medication errors. 1. All prescription documents must be legible. Computerized order entry is the recommended method for writing prescription orders. 2. All prescription orders should be written using the metric system. Standard units should be spelled out (units NOT u). 3. The medication order should always include drug name, exact metric weight or concentration, and dosage form. 4. A leading zero should always precede a decimal expression of less than one. A terminal or trailing zero should never be used after a decimal. 5. Prescription orders should include purpose of medication ( for cough ) unless considered inappropriate by prescriber. 6. Prescribers should include the patient s age when appropriate, and the patient s weight on the prescription. 7. Prescribers should not use vague instructions such as take as directed. 8. Prescribers should avoid the use of abbreviations and Latin directions for medication use. 9

10 Medication errors have been put into categories by type of error. The chart below is excerpted for the Institute for Safe Medication Practices recommendations and the NCCMERP. The Council's definition of "harm" is "death, or temporary or permanent impairment of body function/structure requiring intervention." Intervention may include monitoring a patient's condition, change in therapy, or active medical or surgical treatment. TYPE OF ERROR/CATEGORY NO ERROR: Category A ERROR, NO HARM: Category B Category C Category D ERROR, HARM Category E ERROR, HARM (Continued) Category F Category G Category H ERROR, DEATH Category I RESULT Circumstances or events that have the capacity to cause an error. An error occurred but the medication did not reach the patient An error occurred that reached the patient but did not cause patient harm. An error occurred that resulted in the need for increased patient monitoring but no patient harm. An error occurred that resulted in the need for treatment or intervention and caused temporary patient harm. An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm. An error occurred that resulted in permanent patient harm. An error occurred that resulted in a near-death event (anaphylaxis, cardiac arrest). An error occurred that resulted in patient death. 10

11 Leape, Lucain et al published another classification of errors in the Quality Review Bulletin entitled Preventing Medical Injury in Their description and categories of errors are listed below. CATEGORY Diagnostic Treatment Preventive Other DESCRIPTION Error of delay in diagnosis Failure to employ indicated tests Use of outmoded tests or therapy Failure to act on results of monitoring or testing Error in the performance of an operation, procedure or test Error in administering the treatment Error in the dose or method of using a drug Avoidable delay in treatment or in responding to an abnormal test Inappropriate (not indicated) care Failure to provide prophylactic treatment Inadequate monitoring or follow-up of treatment Failure of communication Equipment failure Other system failures The ISMP web site contains alerts regarding medication errors, warnings regarding medications, consumer tips, and a public message board site ( This site is a must read site for any person in the healthcare industry. A subscription to ISMP s fax alerts on medication errors is probably the best investment a practitioner can make in helping to prevent medication errors. All pharmacies should complete the ISMP Medication Safety Self Assessment for their particular type of practice setting to heighten awareness of the distinguishing characteristics of safe pharmacy systems, and create a baseline of pharmacy efforts to enhance the medication safety and evaluate these efforts over time. The self assessment criteria represent innovative practices and system enhancements which can help reduce medication errors. The U.S. Food and Drug Administration (FDA) has a program known as MEDWATCH. MEDWATCH (Medical Products Reporting Program) identifies medication errors associated with confusing product labels and names by obtaining information from health professionals regarding serious adverse events and medical product problems. MEDWATCH reports are evaluated for clinical significance. Based upon this, the FDA may initiate various actions, including issuing notices to health professionals or ordering product labeling, packaging, or name changes. Safety alerts, Dear health professional letters, public health advisories, talk papers and urgent notices are all actions of the FDA in concert with the pharmaceutical industry and the MEDWATCH program. The MEDWATCH column in the FDA Medical Bulletin also alerts health care practitioners to the possibility of adverse events. For the latest information regarding product alerts consult this website: 11

12 CHAPTER 3 CAUSES OF PHARMACY LIABILITY CLAIMS Medication errors can occur at several points in the current drug therapy system. The Physician Insurers Association of America s Medication Error Study determined that more than $340 million was paid to settle some 7,000 medication error lawsuits, with awards averaging $104,000 per claim. The seven most identified causes of drug therapy claims against physicians include the following: 1. Incorrect or inappropriate dosage. 2. Wrong medication for medical condition. 3. Failure to monitor for side effects. 4. Poor physician/patient communication. 5. Failure to monitor drug levels. 6. Inappropriate length of treatment. 7. Failure to note a drug allergy. Approximately 85% of liability claims against pharmacists are the result of mechanical errors, such as dispensing the wrong drug or wrong strength, and errors in label directions. There has also been an increase in the number of liability claims based on intellectual errors such as failing to detect a prescribing error. From 1989 through June 1997, Kenneth R. Baker, pharmacist and attorney reported the following statistics listed below. Causes of pharmacy liability claims: 1. Wrong drug dispensed (49.3%) 2. Wrong strength dispensed (25.9%) 3. Wrong directions (7.7%) 4. Intellectual errors (17.1%) Pharmacy personnel should read the literature regarding medication errors to ensure their awareness of the nature of medication errors and use this information to help prevent such errors in their practice. Pharmacy-based medication errors have addressed both technical and cognitive errors in pharmacy practice. Following are two brief summaries of preparation and dispensing errors. CALCULATION ERROR In a hospital in Wisconsin, a 3 month-old infant died due to an overdose of Digoxin. The child s Digoxin dose was 17 mcg. Instead, she received 170 mcg daily and subsequently died. 12

13 DISPENSING ERROR A 37 year-old mother of three had been taking Doxepin (an antidepressant) for several months. The same pharmacy that had been filling the drug for her, instead dispensed Loxapine (an antipsychotic). When the patient received the drug, she noticed the label had a different name. She questioned the technician at the pharmacy, and had her verify the medication with the pharmacist. The technician returned with the medication and stated that the drug was correct. The patient took 4 doses and experienced adverse effects of the medication, including loss of control over mental and physical faculties, extreme agitation, disorientation, extreme paranoia, and suicidal tendencies. Upon calling the pharmacy again the next morning, she was told this was not the correct medication. She went to the emergency room for treatment. The pharmacist failed to to properly investigate the accuracy of the prescription. Failure to resolve a potential medication error has caused liability claims to be filed against pharmacy personnel. The following cases are reviewed below. 1. Prescription entered and dispensed for tambocor, a cardiac medication, instead of tamoxifen. The prescriber was known to the pharmacist as an oncologist, yet the prescription was not verified with the prescriber. 2. A prescription was written for Isordil 20mg, four times daily. This illegible prescription was not verified with the prescriber, and Plendil 20mg was dispensed instead. The patient took the medication for one day and the following morning suffered a heart attack and died. 3. A prescription for a pregnant mother for Brethine, a drug used to treat premature labor, was misfilled with methergine, a drug used to stop uterine bleeding. Shortly after the mother took the methergine, the infant died. 4. A female hormone (cycrin) was dispensed to a man instead of Coumadin. The patient took the drug for 11 days after which he suffered a heart attack that left him in a coma. Patient is currently in a special care facility still in a coma. Illegible prescriptions are a daily occurrence in pharmacy. Pharmacy personnel must take the time to verify prescriptions with the prescriber so that mistakes are not made. Some physicians are now utilizing computerized medication systems so this problem can be avoided. Errors due to workload have also been discussed in the press and in the courts. A pharmacist was sued as the result of placing two medications in the wrong vials. A 73 year-old woman received prescriptions for Restoril and Prozac. The patient suffered symptoms of an overdose of Prozac due to the placing of the medications in the wrong vials. The rate of prescription dispensing is an issue that the patient may use in arguing for liability of a pharmacist committing or failing to prevent a medication error. Failure to adopt technology that is part of the standard of practice can also be used against pharmacy personnel. Computer systems that review patient s drug therapy and alert the pharmacists regarding potential drug interactions are standard in the workplace. Filling 13

14 prescriptions for erythromycin and theophyllin resulted in a patient suffering seizures. The pharmacist and the pharmacy were sued and the duty to warn the patient and safeguard the patient against potential interactions was not done. Medication use is a complex process that comprises the sub-processes of medication prescribing, order processing, dispensing, administration, and effects monitoring. The key elements that most often affect the medication use process, and the common failures and medication errors associated with them are listed below. The inter-relationships among these key elements form the structure within which medications are used. 1. Patient information: Obtaining the patient s pertinent demographic and clinical information that will assist practitioners in selecting the appropriate medications, doses and routes of administration. Having essential patient information at the time of medication prescribing, dispensing and administration will result in a significant decrease in preventable adverse drug events (ADEs). 2. Drug information: Providing accurate and usable drug information to all health professionals involved in the medication use process reduces the amount of preventable ADEs. Not only should drug information be readily accessible to the staff through a multitude of sources (drug references, formulary, protocols, dosing scales, etc.), it is imperative that the drug information is up to date as well as accurate. 3. Communication of drug information: Miscommunication between physicians, pharmacists and nurses is a common cause of medication errors. To minimize the amount of medication errors caused by miscommunication, it is always important to verify drug information and eliminate communication barriers. 4. Drug labeling, packaging and nomenclature: Drug names that look-alike, sound-alike, have confusing drug labeling and non-distinct drug packaging significantly contribute to medication errors. The incidence of medication errors is reduced with the use of proper labeling and the use of unit dose systems within hospitals. 5. Drug storage, stock and standardization: Standardizing drug administration times, drug concentrations and limiting the dose concentration of drugs available in patient care areas will reduce the risk of medication errors or minimize their consequences should an error occur. 6. Drug device acquisition, use and monitoring: Appropriate safety assessment of drug delivery devices should be made both prior to their purchase and during their use. Also, a system of independent double-checks should be used within the institution to prevent device related errors such as, selecting the wrong drug or drug concentration, setting the rate improperly, or mixing the infusion line up with another. 14

15 7. Environmental factors: Having a well-designed system offers the best chance of preventing errors; however, sometimes the environment in which we work contributes to medication errors. Environmental factors that often contribute to medications errors include poor lighting, noise, interruptions and a significant workload. 8. Competency and staff education: Staff education should focus on priority topics, such as: new medications being used in the hospital, high-alert medications, medication errors that have occurred both internally and externally, protocols, policies and procedures related to medication use. Staff education can be an important error preventions strategy when combined with the other key elements for medication safety. 9. Patient education: Patients must receive ongoing education from physicians, pharmacists and the nursing staff about the brand and generic names of medications they are receiving, their indications, usual and actual doses, expected and possible adverse effects, drug or food interactions, and how to protect themselves from errors. Patients can play a vital role in preventing medication errors when they have been encouraged to ask questions and seek answers about their medications before drugs are dispensed at a pharmacy or administered in a hospital. 10. Quality processes and risk management: The way to prevent errors is to redesign the systems and processes that lead to errors rather than focus on correcting the individuals who make errors. Effective strategies for reducing errors include making it difficult for staff to make an error and promoting the detection and correction of errors before they reach a patient and cause harm. 15

16 CHAPTER 4 YOU GAVE ME THE WRONG MEDICATION! A patient comes to your pharmacy, walking quickly and purposely toward the counter, looking very angry and shaking her head furiously. She asks to speak to the chief pharmacist -- NOW! You rush over to get the pharmacist. While walking toward the lady, she yells at you, YOU GAVE ME THE WRONG MEDICATION! In an effort to calm and quiet her down, you ask her to come in, sit down, and tell you what happened so you can check things out. She tells you that you refilled her blood pressure medicine the other day and gave her the wrong medicine. What should you do? First, attempt to take the patient to a private area where you can both sit down and talk uninterrupted. Permit the patient to tell you the whole story. Listen, and do not interrupt. Gather as many details as possible. Do NOT admit liability. Do NOT offer to refund the money the patient paid for that prescription. Second, try to examine the prescription vial and determine its contents. Go back to your records and verify who dispensed it and what was dispensed, then check the contents with the actual manufacturer s container. Third, try to determine if the patient took any of the medication. Try to find out if she suffered any harm, what medication was actually taken (as opposed to what was prescribed), and whether or not she saw a doctor or went to an emergency room. Every employer has a policy and procedure regarding Risk Management and dispensing errors. Be sure to read and know how to implement this policy if a dispensing error occurs. In this instance, if a mistake was indeed made, be sure to record all the information as required by your company s policies. Do not attempt to lie to the patient or cover up the mistake. It is important to know that a prescription error by itself, is not negligence. In addition to the dispensing error, a patient must demonstrate damages in order to have a lawsuit. If the patient received the wrong medication but did not take any of it, then the patient did not incur any damages. The patient may report the error to the State Board of Pharmacy. Upon returning the drug to the pharmacy, the patient should be given the correct medication, and using the best people skills one can have, attempt to diffuse the situation. Pharmacy personnel who have the best rapport with that particular patient should be utilized in this tense situation to help in damage control. Dispensing errors are bound to occur in the practice of pharmacy. The question is not whether or not we will ever make a mistake and give a patient the wrong drug, it is instead when will it happen? Many lawyers advise clients to never say sorry when they make a mistake. An apology 16

17 might be evidence of wrongdoing in a civil trial. A health care professional may be taking an even greater risk by refusing to help patients mitigate or control damages after learning that an error was made. Pharmacy personnel may be better advised to cooperate and help minimize the harm caused by a dispensing mistake when asked for help. This approach will ensure that the patients are cared for in the best and most compassionate way. This is a way of reducing the amount of damages that might have to be paid, and is ethically correct. Medication errors present a serious threat to patient welfare and a significant liability to health professionals and their insurers. The subject of medication errors is a stressful topic. These events are both embarrassing and alarming to pharmacy personnel, but should not be ignored or covered up because much can be learned from them. Pharmacists have a responsibility to the patients who depend on them to practice according to acceptable standards of care for the profession. Such standards seek to establish proper procedures for ensuring that pharmacists fill, compound, dispense, and label prescriptions correctly. When there is a deviation from the standard of care, an error occurs. Any action or conduct that deviates from the standard of care is negligent, and the pharmacy/pharmacist may be considered liable for the act. If the patient suffered injuries or damages, a lawsuit may be forthcoming. The last criterion for legal action is that the negligent act must be the cause of the patient s damages. Several other theories of liability by which a lawsuit may occur are claims of breach of implied warranty and breach of expressed warranty. Breach of implied warranty stems from the warranty of fitness for sale of the product. If a product is found to be contaminated, then breach of implied warranty can occur. Breach of expressed warranty occurs when pharmacy personnel make any expressed claim about a product that the product fails to meet. Stating that a particular over the counter item can cure a problem just as good as a prescription can open up the person claiming this to possible litigation. Depending on the jurisdiction, the patient s cause of action may start to accrue when the act was performed, when the injury first occurred, or when the patient discovered the existence and cause of the injury. If a patient does not initiate a lawsuit within two years of these events, usually the patient is barred from bringing the suit thereafter. In summary, to avoid medication errors and minimize the chances for being sued, the following advice is given: 1. Keep doing what you ve been taught to do, and try to minimize the interruptions, telephone calls, questions and other distractions that do not allow you to focus on what you are doing. 2. Do not try to fill more than one prescription at a time. 3. If you have any question in your mind about the prescription, what it says, or how to fill it, ask for help. 4. Read the label 3 times- double check your work. Do not be afraid to allow others to double check your work, ask for advice when questions arise. 5. Remember what your job is- MAXIMIZE THERAPY, MINIMIZE RISKS. 17

18 Fill each medication as if it were intended for you or a member of your family. READ LABELS THREE TIMES 1. When you select the drug product from a storage area or medication drawer 2. When you prepare, label, dispense or administer the product 3. When you return the original container or package to the storage area or discard it A medication error reduction tip from hospital pharmacy and Roxanne Laboratories. 18

19 REFERENCES 1. Maslakowski, CJ. Cut adverse drug reactons with clinical decision support. Health Management Technology. August, Fitzgerald WL. Wilson, DB. Medication errors: Lessons in law. Drug Topics. Jan Vivian, JC. Stonewall Liability. US Pharmacist. November, Friend, T. Drug errors kill outpatients at a rising rate. USA Today. February 27, American Society of Health-System Pharmacists. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Hosp Pharm. 1993; 50: Davis NM, Cohen MR. Medication error reduction through continuous quality improvement. Institute for Safe Medication Practices, Leape LL, et al. Systems analysis of adverse events. JAMA. 1995; 274: Bates EW. Medication Errors: How common are they and what can be done to prevent them. Drug Safety. 1996; 15 (5): The National Coordinating Council for Medication Error Reporting and Prevention. News Release: Medication Errors Council Promotes Categorization Index. September 4, MEDWATCH Continuing Education Article. The Clinical Impact of Adverse Event Reporting. Goldman SA, et al. Food and Drug Administration, October Work DR. Madigan MA. Initiatives for Medication Error Reduction. US Pharmacist. August Cacciatore G. Pharmacy, technology and the law-combining innovation and reason. Technology and Pharmacy, Stephenson, J. Targeting medical errors. JAMA 2000 Jan 19; 283 (3). 14. Richardson, WC. To err is human: Building a safer health system. Opening Statement, IOM Public Briefing 1991 Dec Schneider, P; Hopefl, A., et. Al. Medication errors: Integrating individual and system accountability. AJHP 1999 June 15; 56:

20 16. Moray, N. Error reduction as a systems problem. In Marilyn Sue Bogner (Ed), Human Error in Medicine. Lawrence Eribaum Associates, Hillsdale, NJ 1994; Vogel, S. Army doctor charged in girl s death: Antibiotic treatment, truthfulness at issue. Washington Post 2000 March 22, page B Crane, V.S. New perspectives on preventing medication errors and adverse drug events. AJHP : Waller, R, Grealy, M. Avoid culture of blame. USA today 1999 Dec Moore Jr., Duncan, J. Accident insurance: Dana-Farber seeks foolproof ways to stop medical errors. Modern Healthcare 1997 Arp 21; 27 (16) Cohen, M. Medication errors: Causes, prevention, and risk management.. Jones and Bartlett Publishers, Inc. November Bridge Medical, Inc. Beyond Blame video. 23. Smetzer, JL. Lessons from Colorado: Beyond blaming individuals. Nursing 98, May. 20

21 Medication Safety: Patient Safety Focus Final Exam 1. Of the following, the largest number of deaths that occur yearly are attributed to: A. motor vehicle accidents B. AIDS C. preventable medical errors D. breast cancer 2. How much money is dedicated to patient safety in the FDA s 2003 budget? A. $22 million B. $5 million C. $60 million D. $10 million 3. The largest number of deaths due to medication errors was caused by errors in A. dosage B. wrong drug C. A+B D. wrong patient 4. Most potential ADE s occur at what stage of the medication process? A. dispensing B. ordering C. administration D. transcription 5. Adverse drug events are the cause of how many hospitalizations every year? A. 8 million B. 8.8 million C. 61,000 D. 32,000 21

22 6. The most common mistakes accounting for medication errors included: A. overdosing B. prescribing meds to a patient that is allergic C. duplicate therapy D. all the above 7. The problems and sources of medication errors are attributed to A. bad apples B. fragmented nature of health care C. bad drugs D. bad equipment 8. An illegible prescription is an example of what type of medication error? A. prescribing error B. dispensing error C. patient compliance error D. none of the above 9. Medication errors can be decreased by which of the following A. communication B. reasonable workload C. multiple procedure and final product checks D. all of the above 10. Administering to the patient medication not prescribed for that patient is an example of what type of medication error? A. prescribing error B. dispensing error C. unauthorized drug error D. omission error 11. The failure to administer an ordered dose to a patient before the next scheduled dose, if any, is classified as A. prescribing error B. improper dose error C. wrong time error D. omission error 22

23 12. Failure to review a prescribed regimen for appropriateness and detection of problems is an example of what type of medication error? A. prescribing error B. dispensing error C. monitoring error D. omission error 13. What percent of errors in the USP s Medication Error Reporting Program is the result of poor handwriting? A. 5% B. 10% C. 20% D. 15% 14. All the following drugs are classified as high alert medications except A. IV isotonic saline B. IV magnesium sulfate C. IV calcium D. insulin 15. An error that occurred but did NOT reach the patient is categorized as the following type of error: A. Category A B. Category B C. Category C D. Category D 16. An error that resulted in a patient death is categorized a the following type of error: A. Category A B. Category G C. Category H D. Category I 23

24 17. The type of error that reaches the patient but does not cause the patient harm is classified as A. Category A B. Category B C. Category C D. Category D 18. The Quality Review Bulletin lists the errors that are due to failure to act on results of testing as A. treatment error B. diagnostic error C. preventive error D. other error 19. The agency, which is a part of the FDA, that identifies medication errors associated with confusing product labels is: A. ISMP B. FDA C. MEDWATCH D. MERP 20. Approximately 85% of liability claims against pharmacist are the result of A. mechanical errors B. intellectual errors C. monitoring errors D. implied warranty errors 21. The drug associated with several infant deaths due to calculation error is A. Digoxin B. Tambocor C. Tamoxifen D. Doxepin 24

25 22. When a dispensing error is made, the pharmacist in charge should do the following: A. avoid the patient B. cover-up the incident C. attempt to discuss the incident with the patient D. say you are sorry 23. If a medication error is dispensed, but the patient discovers the error, does not take the medication or suffer any damages, the chances of a liability claim are A. increased B. decreased C. stays the same D. none of the above 24. What class of drugs are involved in most medication errors? A. antimicrobials B. cardiovascular agents C. gastrointestinal agents D. hormonal agents 25. Breach of implied warranty occurs when the product for sale is found to be contaminated or unfit for sale. A. True B. False 25