Preventing Medication Errors

P12. Preventative Care: Preventing Medication Errors, 3 CE-hours, $21

Course Description: The course deals with the prevention of medication errors as part of medical errors. Medication errors are usually the largest part of medical errors. Prevention is discussed in the framework of patient safety. It list and discusses the types of medication errors that are common in health-care settings. The various ways to prevent medication errors are listed and explained. In order to evaluate and reduce medication errors, a well designed reporting system is required.


  1. Distinguish the common types of medical errors and how they can be prevented.
  2. Describe how you can Improve patient safety through the various procedures, protocols and policies that impact patients.
  3. List the common medication errors that can make a medical setting unsafe for patients.
  4. Discuss the prevention of medication errors in various settings for different populations.
  5. Evaluate the various reporting systems and approaches that deal with medication errors.

Course Format: Online linked resources and lectures that you can use anytime 24/7. One multi-choice test.

Course Developers and Instructors: R. Klimes, PhD, MPH (John Hopkins U), author of articles on overall health and wellness prevention.

Course Time: About thirty hours for online study, test taking with course evaluation feedback and certificate printing.

Continuing education online courses in Preventing Medication Errors.


Professor Rudolf Klimes, PhD, welcomes you to this online course. Keep going.

START the course here. TAKE the exam at the end. PAY after the exam.

Course Test 6660

: Click here for the self-correcting test that requires 75% for a passing grade.


Course Outline

  1. Preventing Medical Errors: An epidemic of errors, where do they occur, their costs, associated fears, the system problem.
  2. Improving Patient Safety: Match needs with capacity, have clear communication, specific setting for care, assigned work-spaces.
  3. Types of Medication Errors: categories of errors, patients at risk, and how do errors happen.
  4. Preventing Medication Errors: prevention via prescriptions, regulations, classification, labeling, and tracking.
  5. Reporting Medication Errors: computerized systems, using report data, evaluation of safety, charting, administrative databases,claims, and audits.


P12  Preventing Medication Errors.  3 CE course hours

FDA and ISMP Work to Prevent Medication Errors - (JPG)

What’s wrong with this picture? The strength looks different for one of these medications, even though all mean the same thing—5 mg. The problem is that one of them uses an unnecessary zero after the decimal point. Sometimes prescriptions are written this way and the decimal point can be missed, leading to a tenfold overdose (50 mg instead of 5 mg). This is one example of a potential preventable medication error.


1. Preventing Medical Errors

One in seven Medicare patients in hospitals experience a medical error. But medical errors can occur anywhere in the health care system: In hospitals, clinics, surgery centers, doctors’ offices, nursing homes, pharmacies, and patients’ homes. Errors can involve medicines, surgery, diagnosis, equipment, or lab reports. They can happen during even the most routine tasks, such as when a hospital patient on a salt-free diet is given a high-salt meal.

Source: Agency for Healthcare Research and Quality

If you are taking the 30 Hour Prevention of Disease Course, you have already read the first three articles below in the previous module. Skip to the new stuff.

An Epidemic of Errors

Medical Errors: The Scope of the Problem

Fact sheet, Publication No. AHRQ 00-P037. Agency for Healthcare Research and Quality, Rockville, MD.

An Epidemic of Errors: An Overview

The November 1999 report of the Institute of Medicine (IOM), entitled To Err Is Human: Building A Safer Health System, focused a great deal of attention on the issue of medical errors and patient safety. The report indicated that as many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors.

Even using the lower estimate, this would make medical errors the eighth leading cause of death in this country—higher than motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516). About 7,000 people per year are estimated to die from medication errors alone—about 16 percent more deaths than the number attributable to work-related injuries.

The President ordered the Quality Interagency Coordination Task Force to make recommendations on improving health care quality and protecting patient safety in response to the IOM report. The Report to the President on Medical Errors was issued in February 2000. For more information on medical errors, select

[1.1]  Where Errors Occur

Errors occur not only in hospitals but in other health care settings, such as physicians’ offices, nursing homes, pharmacies, urgent care centers, and care delivered in the home. Unfortunately, very little data exist on the extent of the problem outside of hospitals. The IOM report indicated, however, that many errors are likely to occur outside the hospital. For example, in a recent investigation of pharmacists, the Massachusetts State Board of Registration in Pharmacy estimated that 2.4 million prescriptions are filled improperly each year in the State.

[1.2] Costs

Medical errors carry a high financial cost. The IOM report estimates that medical errors cost the Nation approximately $37.6 billion each year; about $17 billion of those costs are associated with preventable errors. About half of the expenditures for preventable medical errors are for direct health care costs.

Not a New Issue

The serious problem of medical errors is not new, but in the past, the problem has not gotten the attention it deserved. A body of research describing the problem of medical errors began to emerge in the early 1990s with landmark research conducted by Lucian Leape, M.D., and David Bates, M.D., and supported by the Agency for Health Care Policy and Research, now the Agency for Healthcare Research and Quality (AHRQ).

The final report of the President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry, released in 1998, identified medical errors as one of the four major challenges facing the Nation in improving health care quality. Based on the recommendations of that report, President Clinton directed the establishment of the Quality Interagency Coordination Task Force (QuIC) to coordinate quality improvement activities in Federal health care programs.

The QuIC includes: the Departments of Health and Human Services, Labor, Veterans Affairs, Commerce, and Defense; the Coast Guard; the Bureau of Prisons; and the Office of Personnel Management.

[1.3]  Public Fears

While there has been no unified effort to address the problem of medical errors and patient safety, awareness of the issue has been growing. Americans have a very real fear of medical errors. According to a national poll conducted by the National Patient Safety Foundation:

  • Forty-two percent of respondents had been affected by a medical error, either personally or through a friend or relative.
  • Thirty-two percent of the respondents indicated that the error had a permanent negative effect on the patient’s health.

Overall, the respondents to this survey thought the health care system was “moderately safe” (rated a 4.9 on a 1 to 7 scale, where 1 is not safe at all and 7 is very safe).

Another survey, conducted by the American Society of Health-System Pharmacists, found that Americans are “very concerned” about:

  • Being given the wrong medicine (61 percent).
  • Being given two or more medicines that interact in a negative way (58 percent).
  • Complications from a medical procedure (56 percent).

Most people believe that medical errors are the result of the failures of individual providers. When asked in a survey about possible solutions to medical errors:

  • Seventy-five percent of respondents thought it would be most effective to “keep health professionals with bad track records from providing care.”
  • Sixty-nine percent thought the problem could be solved through “better training of health professionals.”

This fear of medical errors was borne out by the interest and attention that the IOM report generated. According to a survey by the Kaiser Family Foundation, 51 percent of Americans followed closely the release of the IOM report on medical errors.

[1.4] It’s a Systems Problem

The IOM emphasized that most of the medical errors are systems related and not attributable to individual negligence or misconduct. The key to reducing medical errors is to focus on improving the systems of delivering care and not to blame individuals. Health care professionals are simply human and, like everyone else, they make mistakes. But research has shown that system improvements can reduce the error rates and improve the quality of health care:

  • A 1999 study indicated that including a pharmacist on medical rounds reduced the errors related to medication ordering by 66 percent, from 10.4 per 1,000 patient days to 3.5 per 1,000 patient days.
  • The specialty of anesthesia has reduced its error rate by nearly sevenfold, from 25 to 50 per million to 5.4 per million, by using standardized guidelines and protocols, standardizing equipment, etc.
  • One hospital in the Department of Veterans Affairs uses hand-held, wireless computer technology and bar-coding, which has cut overall hospital medication error rates by 70 percent. This system is soon to be implemented in all VA hospitals.

[1.5] Types of Errors

The IOM defines medical error as “the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim.” An adverse event is defined as “an injury caused by medical management rather than by the underlying disease or condition of the patient.” Some adverse events are not preventable and they reflect the risk associated with treatment, such as a life-threatening allergic reaction to a drug when the patient had no known allergies to it. However, the patient who receives an antibiotic to which he or she is known to be allergic, goes into anaphylactic shock, and dies, represents a preventable adverse event.

Most people believe that medical errors usually involve drugs, such as a patient getting the wrong prescription or dosage, or mishandled surgeries, such as amputation of the wrong limb. However, there are many other types of medical errors, including:

  • Diagnostic error, such as misdiagnosis leading to an incorrect choice of therapy, failure to use an indicated diagnostic test, misinterpretation of test results, and failure to act on abnormal results.
  • Equipment failure, such as defibrillators with dead batteries or intravenous pumps whose valves are easily dislodged or bumped, causing increased doses of medication over too short a period.
  • Infections, such as nosocomial and post-surgical wound infections.
  • Blood transfusion-related injuries, such as giving a patient the blood of the incorrect type.
  • Misinterpretation of other medical orders, such as failing to give a patient a salt-free meal, as ordered by a physician.

[1.6] Preventing Errors

Research clearly shows that the majority of medical errors can be prevented:

  • One of the landmark studies on medical errors indicated 70 percent of adverse events found in a review of 1,133 medical records were preventable; 6 percent were potentially preventable; and 24 percent were not preventable.
  • A study released last year, based on a chart review of 15,000 medical records in Colorado and Utah, found that 54 percent of surgical errors were preventable.

Other potential system improvements include:

  • Use of information technology, such as hand-held bedside computers, to eliminate reliance on handwriting for ordering medications and other treatment needs.
  • Avoidance of similar-sounding and look-alike names and packages of medication.
  • Standardization of treatment policies and protocols to avoid confusion and reliance on memory, which is known to be fallible and responsible for many errors.

Source: Medical Errors: The Scope of the Problem. Fact sheet, Publication No. AHRQ 00-P037. Agency for Healthcare Research and Quality, Rockville, MD.

FDA and ISMP Work to Prevent Medication Errors - (JPG)

1.7 Reducing Errors in Health Care

Translating Research Into Practice: Reducing Errors in Health Care

Agency for Healthcare Research and Quality, April 2000

Medical errors are responsible for injury in as many as 1 out of every 25 hospital patients; an estimated 48,000-98,000 patients die from medical errors each year. Errors in health care have been estimated to cost more than $5 million per year in a large teaching hospital, and preventable health care-related cost the economy from $17 to $29 billion each year.

Agency for Healthcare Research and Quality (AHRQ) research has shown that medical errors may result most frequently from systems errors—organization of health care delivery and how resources are provided in the delivery system.

Patients at Risk

Medical errors may result in:

  • A patient inadvertently given the wrong medicine.
  • A clinician misreading the results of a test.
  • An elderly woman with ambiguous symptoms (shortness of breath, abdominal pain, and dizziness) whose heart attack is not diagnosed by emergency room staff.

Errors like these are responsible for preventable injury in as many as 1 out of every 25 hospital patients.

Errors in health care have been estimated to cost more than $5 million per year in a large teaching hospital. According to a recent report by the Institute of Medicine (IOM)3, preventable health care-related injuries cost the economy from $17 to $29 billion annually, of which half are health care costs.

The IOM report estimates that 44,000 to 98,000 people each year die from medical errors. Even the lower estimate is higher than the annual mortality from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516), thus making medical errors the eighth leading cause of death in the United States.

These and other findings of the IOM report are based on research sponsored by a variety of organizations, including the Agency for Healthcare Research and Quality (AHRQ).

For example, a study by AHRQ found that just one type of error—preventable adverse drug events—caused one out of five injuries or deaths per year to patients in the hospitals that were studied.

How Errors Occur

Errors can occur at any point in the health care delivery system, AHRQ-supported research has revealed.


These are preventable mistakes in prescribing and delivering medication to patients, such as prescribing two or more drugs whose interaction is known to produce side effects or prescribing a drug to which the patient is known to be allergic.

Research by AHRQ-supported investigators is helping to characterize these errors (called preventable adverse drug events, or ADEs) and suggest how to prevent them.

  • In a study of inpatient care in two tertiary care hospitals, errors in ordering and administering medicines accounted for 56 and 34 percent, respectively, of preventable adverse drug events.
  • Findings from a second study showed that dosage errors, in particular, were primarily due to the physician’s lack of knowledge about the drug or about the patient for whom it was prescribed.
  • An attempt to identify risk factors for preventable adverse drug reactions among patients admitted to medical and surgical units at two large hospitals7 found few such factors, which suggested to the researchers that a focus on improving medication systems would prove more effective.


In contrast to ADEs, surgical adverse events (1 in 50 admissions in Colorado and Utah hospitals during 1992), accounted for two-thirds of all adverse events and 1 of 8 hospital deaths in a recent retrospective study of these institutions by an AHRQ fellow.


Incorrect diagnoses may lead to incorrect and ineffective treatment or unnecessary testing, which is costly and sometimes invasive. Also, inexperience with a technically difficult diagnostic procedure can affect the accuracy of the results. Here, too, AHRQ-funded researchers have made major contributions.

  • One study showed that physicians who performed 100 or more colposcopies (a test used to follow up abnormal Pap smears) a year had more accurate findings than physicians who performed the procedure less often.
  • Another study demonstrated that measuring blood pressure with the most commonly used type of equipment often gives incorrect readings that may lead to mismanagement of hypertension.


Although errors in medication, surgery, and diagnosis are the easiest to detect, medical errors may result more frequently from the organization of health care delivery and the way that resources are provided to the delivery system. Research by AHRQ-supported scientists is helping to identify the systemic factors contributing to preventable adverse events.

  • Investigators in a major stud discovered that failures at the system level were the real culprits in over three-fourths of adverse drug events.
  • Failures in disseminating pharmaceutical information, in checking drug doses and patient identities, and in making patient information available are system errors that accounted for adverse drug events in over half of the hospitals studied.
  • One system-level factor, staffing levels of nurses (adjusted for hospital characteristics), was found in a study to influence the incidence of adverse events following major surgery, such as urinary tract infections, pneumonia, thrombosis, and pulmonary compromise.

This research on systemic problems leads investigators to conclude that any effort to reduce medical errors in an organization requires changes to the system design, including possible reorganization of resources by top-level management.

Source: Reducing Errors in Health Care: Translating Research into Practice. AHRQ Publication No. 00-PO58, April 2000


2.  Improving Patient Safety

Translating Research Into Practice: Reducing Errors in Health Care

Agency for Healthcare Research and Quality, April 2000

Research funded by AHRQ and others has been important in identifying the extent and causes of errors. Now, additional research is needed to develop and test better ways to prevent errors, often by reducing the reliance on human memory. Some areas of past research that have shown promise in helping to reduce errors include computerized ADE monitoring, computer-generated reminders for followup testing, and standardized protocols.


Although chart review was found in an AHRQ-funded study to be more accurate than computer tracking and voluntary reporting in identifying adverse drug events, it required five times more personnel time. Researchers concluded that the computerized method was the most efficient means of tracking drug errors.


Some diagnostic tests must be repeated to follow up certain conditions, but a small number of such repeat tests are done too early to yield useful results. In contrast, laboratory results showing that a patient needs critical care may not be communicated in a timely manner.

  • One study funded by AHRQ found that a computerized reminder system to alert physicians to the proper timing of repeat tests reduced the number of patients who were subjected to unnecessary repeat testing.
  • The same research group subsequently reported that an automatic alerting system for communicating critical laboratory results reduced the time until appropriate treatment when compared with the existing hospital paging system.


An AHRQ-sponsored study of patients in intensive care units who had severe respiratory disease found a four-fold increase in survival rate with the use of computerized treatment protocols.

Still other investigators are testing computerized decision support systems in various patient populations. All of these research efforts reflect AHRQ’s commitment to improving patient safety by providing new tools to augment provider judgment.

AHRQ-funded research continues to create and test methods to help clinicians avoid errors in health care delivery. An investigation funded by AHRQ and the National Institute on Aging will address the incidence and preventability of adverse drug events in elderly patients receiving ambulatory care.

The Agency has recently funded four Centers for Education and Research in Therapeutics (CERTs) as part of a 3-year demonstration program. The CERTs will conduct research to increase understanding of ways to improve the appropriate and effective use of drugs, biologicals, and devices in treatments and to avoid adverse events. These centers will also add to our knowledge of the possible risks of new uses of drugs, and combinations of drugs, as they are prescribed in everyday practice.

In addition, the Agency has recently announced that it will enter into cooperative agreements with nonprofit and for-profit health care organizations to test the effectiveness of the transfer and application of systems-based best practices to reduce medical errors and improve patient safety. This research will help identify high-risk patients or patient groups, providers, health care processes and settings, as well as developing generalizable methods for error reduction.

Source: Reducing Errors in Health Care: Translating Research into Practice. AHRQ Publication No. 00-PO58, April 2000

Toward Patient Safety: Safe Practices for Better Health Care

30 Safe Practices for Better Health Care

Agency for Healthcare Research and Quality, March 2005

Fact Sheet

One reason adverse events and medical errors occur is that evidence-based information on what works to prevent them, or reduce the harm they cause, is not available.

The National Quality Forum, with support from the Agency for Healthcare Research and Quality (AHRQ), has identified 30 safe practices that evidence shows can work to reduce or prevent adverse events and medical errors.


The goal in the United States is to deliver safe, high-quality health care to patients in all clinical settings. Despite the best intentions, however, a high rate of largely preventable adverse events and medical errors occur that cause harm to patients. Adverse events and medical errors can occur in any health care setting in any community in this country.

The 30 safe practices that follow have been endorsed by the membership of the National Quality Forum, which includes representatives of 260 of the Nation’s leading health care provider, purchaser, and consumer organizations. These organizations strongly urge that these 30 safe practices be universally adopted by all applicable health care settings to reduce the risk of harm to patients.

Creating a Culture of Safety

1. Create a health care culture of safety. There is a need to promote a culture that overtly encourages and supports the reporting of any situation or circumstance that threatens, or potentially threatens, the safety of patients or caregivers and that views the occurrence of errors and adverse events as opportunities to make the health care system better.

Matching Health Care Needs with Service Delivery Capability

2. For designated high-risk, elective surgical procedures or other specified care, patients should be clearly informed of the likely reduced risk of an adverse outcome at treatment facilities that have demonstrated superior outcomes and should be referred to such facilities in accordance with the patient’s stated preference.

3. Specify an explicit protocol to be used to ensure an adequate level of nursing based on the institution’s usual patient mix and the experience and training of its nursing staff.

4. All patients in general intensive care units (both adult and pediatric) should be managed by physicians having specific training and certification in critical care medicine (“critical care certified”).

5. Pharmacists should actively participate in the medication-use process, including, at a minimum, being available for consultation with prescribers on medication ordering, interpretation and review of medication orders, preparation of medications, dispensing of medications, and administration and monitoring of medications.

Facilitating Information Transfer and Clear Communication

6. Verbal orders should be recorded whenever possible and immediately read back to the prescriber; that is, a health care provider receiving a verbal order should read or repeat back the information that the prescriber conveys in order to verify the accuracy of what was heard.

7. Use only standardized abbreviations and dose designations.

8. Patient care summaries or other similar records should not be prepared from memory.

9. Ensure that care information, especially changes in orders and new diagnostic information, is transmitted in a timely and clearly understandable form to all of the patient’s current health care providers who need that information to provide care.

10. Ask each patient or legal surrogate to recount what he or she has been told during the informed consent discussion.

11. Ensure that written documentation of the patient’s preference for life-sustaining treatments is prominently displayed in his or her chart.

12. Implement a computerized prescriber-order entry system.

13. Implement a standardized protocol to prevent the mislabeling of radiographs.

14. Implement standardized protocols to prevent the occurrence of wrong-site or wrong-patient procedures.

In Specific Settings or Processes of Care

15. Evaluate each patient undergoing elective surgery for risk of an acute ischemic cardiac event during surgery, and provide prophylactic treatment for high-risk patients with beta blockers.

16. Evaluate each patient upon admission, and regularly thereafter, for the risk of developing pressure ulcers. This evaluation should be repeated at regular intervals during care. Clinically appropriate preventive methods should be implemented consequent to the evaluation.

17. Evaluate each patient upon admission, and regularly thereafter, for the risk of developing deep vein thrombosis/venous thromboembolism. Utilize clinically appropriate methods to prevent both.

18. Utilize dedicated anti-thrombotic (anti-coagulation) services that facilitate coordinated care management.

19. Upon admission, and regularly thereafter, evaluate each patient for the risk of aspiration.

20. Adhere to effective methods of preventing central venous catheter-associated bloodstream infections.

21. Evaluate each pre-operative patient in light of his or her planned surgical procedure for the risk of surgical site infection, and implement appropriate antibiotic prophylaxis and other preventive measures based on that evaluation.

22. Utilize validated protocols to evaluate patients who are at risk for contrast media-induced renal failure, and utilize a clinically appropriate method for reducing risk of renal injury based on the patient’s kidney function evaluation.

23. Evaluate each patient upon admission, and regularly thereafter, for risk of malnutrition. Employ clinically appropriate strategies to prevent malnutrition.

24. Whenever a pneumatic tourniquet is used, evaluate the patient for the risk of an ischemic and/or thrombotic complication, and utilize appropriate prophylactic measures.

25. Decontaminate hands with either a hygienic hand rub or by washing with a disinfectant soap prior to, and after, direct contact with the patient or objects immediately around the patient.

26. Vaccinate health care workers against influenza to protect both them and patients.

Increasing Safe Medication Use

27. Keep workspaces where medications are prepared clean, orderly, well lit, and free of clutter, distraction, and noise.

28. Standardize the methods for labeling, packaging, and storing medications.

29. Identify all “high alert” drugs (for example, intravenous adrenergic agonists and antagonists, chemotherapy agents, anti-coagulants and anti-thrombotics, concentrated parenteral electrolytes, general anesthetics, neuromuscular blockers, insulin and oral hypoglycemics, narcotics, and opiates).

30. Dispense medications in unit-dose or, when appropriate, unit-of-use form, whenever possible.

Source: 30 Safe Practices for Better Health Care: Fact Sheet. March 2005. Agency for Healthcare Research and Quality, Rockville, MD.


3. Types of Medication  Errors

Classification of Medication Errors

The best way to understand how medication errors happen and how to prevent them is to consider their classification, which can be contextual, modal, or psychological. Contextual classification deals with the specific time, place, medicines, and people involved. Modal classification examines the ways in which errors occur (e.g. by omission, repetition, or substitution). However, classification based on psychological theory is to be preferred, as it explains events rather than merely describing them. Its disadvantage is that it concentrates on human rather than systems sources of errors. These classifications have been discussed in detail elsewhere.

Psychologists consider an error to be a disorder of an intentional act, and they distinguish between errors in planning an act and errors in its execution. If a prior intention to reach a specified goal leads to action, and the action leads to the goal, all is well. If the plan of action contains some flaw, that is a ‘mistake’. If a plan is a good one but is badly executed, that is a failure of skill.

This approach yields four broad types of medication error. Mistakes can be divided into (i) knowledge-based errors and (ii) rule-based errors. Failures of skill can be divided into (iii) action-based errors (‘slips’, including technical errors) and (iv) memory-based errors (‘lapses’).

Knowledge-based errors can be related to any type of knowledge, general, specific, or expert. It is general knowledge that penicillins can cause allergic reactions; knowing that your patient is allergic to penicillin is specific knowledge; knowing that co-fluampicil contains penicillins is expert knowledge. Ignorance of any of these facts could lead to a knowledge-based error.

Rule-based errors can further be categorized as (a) the misapplication of a good rule or the failure to apply a good rule; and (b) the application of a bad rule.

An action-based error is defined as ‘the performance of an action that was not what was intended. A slip of the pen, when a doctor intends to write diltiazem but writes diazepam, is an example. Technical errors form a subset of action-based errors. They have been defined as occurring when ‘an outcome fails to occur or the wrong outcome is produced because the execution of an action was imperfect’. An example is the addition to an infusion bottle of the wrong amount of drug.

Memory-based errors occur when something is forgotten; for example, giving penicillin, knowing the patient to be allergic, but forgetting.

Source: Aronson, Jeffrey K. Medication errors: definitions and classification

Errors have been classified as errors, mistakes, slips, violated rules, unperformed actions, and  lapses.

Preventing Medication Errors

The classification of medication errors based on a psychological approach
Wolters Kluwer Health/Adis©; Adis Data Information BV (2006) Source

Reducing Medication Errors

Strategies to Reduce Medication Errors:
Working to Improve Medication Safety

U.S. Food and Drug Administration

When Jacquelyn Ley shattered her elbow on the soccer field, her parents set out to find her the best care in Minneapolis. “We drove past five other hospitals to get to the one we wanted,” says Carol Ley, M.D., an occupational health physician. Her husband, an orthopedic surgeon, made sure Jacquelyn got the right surgeon. After a successful three-hour surgery to repair the broken bones, Jacquelyn, who was 9 at the time, received the pain medicine morphine through a pump and was hooked up to a heart monitor, breathing monitor, and blood oxygen monitor. Her recovery was going so well that doctors decided to turn off the morphine pump and to forgo regular checks of her vital signs.

Carol Ley slept in her daughter’s hospital room that night. When she woke up in the middle of the night and checked on her, Jacquelyn was barely breathing. “I called her name, but she wouldn’t respond,” she says. “I shook her and called for help.” The morphine pump hadn’t been shut down, but had accidentally been turned up high. The narcotic flooded Jacquelyn’s body. She survived the overdose, but it was a close call. “If three more hours had gone by, I don’t think Jacquelyn would have survived,” Ley says. “Fortunately, I woke up.”

Ley was pleased with the way the hospital handled the error. “They came right out and said the morphine pump was incorrectly programmed, they told me the steps they were going to take to make sure Jacquelyn was OK, and they also told me what they were going to do to make sure this kind of mistake won’t happen again. And that’s very important to me.” The hospital began using pumps that are easier to use and revamped nurses’ training. Ley believes there were many contributors to the error, including the fact that it was Labor Day weekend and there were staff shortages. “It goes to show that this can happen to anyone, anywhere,” says Ley, who now chairs the board of the National Patient Safety Foundation.

Multiple Factors

Since 1992, the Food and Drug Administration has received nearly 30,000 reports of medication errors. These are voluntary reports, so the number of medication errors that actually occur is thought to be much higher. There is no “typical” medication error, and health professionals, patients, and their families are all involved. Some examples:

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, though the death couldn’t be linked to the error because the patient was already severely ill.

An older 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. Some dosing mix-ups have occurred because daily dosing of methotrexate is typically used to treat people with cancer, while low weekly doses of the drug have been prescribed for other conditions, such as arthritis, asthma, and inflammatory bowel disease.

One patient died because 20 units of insulin was 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 transdermal 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.

These and other medication errors reported to the FDA may stem from poor communication; misinterpreted handwriting; drug name confusion; confusing drug labels, labeling, and packaging; lack of employee knowledge; and lack of patient understanding about a drug’s directions. “But it’s important to recognize that such errors are due to multiple factors in a complex medical system,” says Paul Seligman, M.D., director of the FDA’s Office of Pharmacoepidemiology and Statistical Science. “In most cases, medication errors can’t be blamed on a single person.”

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 25 national and international organizations, including the FDA, examines and evaluates medication errors and recommends strategies for error prevention.

A Regulatory Approach

The public took notice in 1999 when the Institute of Medicine (IOM) released a report, “To Err is Human: Building a Safer Health System.” 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 each year are 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 addition, the U.S. Department of Health and Human Services (HHS) and other federal agencies formed the Quality Interagency Coordination Task Force in 2000 and issued an action plan for reducing medical errors. In 2001, former HHS Secretary Tommy G. Thompson 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.

The FDA enhanced its efforts to reduce medication errors by dedicating more resources to drug safety, which included forming a new division on medication errors at the agency in 2002. “FDA works to prevent medication errors before a drug reaches the market and monitors any errors that may occur after that,” says Jerry Phillips, R.Ph., former director of the FDA’s Division of Medication Errors and Technical Support.

Here’s a look at key areas in which the FDA is working to reduce medication errors.

Bar code label rule: After a public meeting in July 2002, the FDA decided to propose a new rule requiring bar codes on certain drug and biological product labels. Health care professionals would use bar code scanning equipment, similar to that used in supermarkets, to make sure that the right drug in the right dose and route of administration is given to the right patient at the right time.

“It’s a promising way to automate aspects of medication administration,” says Robert Krawisz, former executive director of the National Patient Safety Foundation. “The technology’s impact at VA hospitals so far has been amazing.” The Department of Veterans Affairs (VA) already uses bar codes nationwide in its hospitals, and the result has been a drastic reduction in medication errors. For example, the VA medical center in Topeka, Kan., has reported that bar coding reduced its medication error rate by 86 percent over a nine-year period.

Here’s how it works: When patients enter the hospital, they get a bar-coded identification wristband that can transmit information to the hospital’s computer, says Lottie Lockett, R.N., a nursing administrator at the Houston VA Medical Center. Nurses have laptop computers and scanners on top of medication carts that they bring to patients’ rooms. Nurses use the scanners to scan the patient’s wristband and the medications to be given. The bar codes provide unique, identifying information about drugs given at the patient’s bedside. “Before giving medications, nurses use the scanner to pull up a patient’s full name and social security number on the laptops, along with the medications,” Lockett says. “If there is not a match between the patient and the medication or some other problem, a warning box pops up on the screen.”

The FDA’s final rule on bar code labeling was published on Feb. 26, 2004. The rule, which took effect on April 26, 2004, applies to prescription drugs, biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research), and over-the-counter (OTC) drugs that are commonly used in hospitals. Manufacturers, repackers, relabelers, and private label distributors of prescription and OTC drugs would be subject to the bar code requirements. The agency continues to study whether it also should develop a rule requiring bar code labeling on medical devices.

Drug name confusion: To minimize confusion between drug names that look or sound alike, the FDA reviews about 300 drug names a year before they are marketed. “About one-third of the names that drug companies propose are rejected,” says Phillips. The agency tests drug names with the help of about 120 FDA health professionals who volunteer to simulate real-life drug order situations. “FDA also created a computerized program that assists in detecting similar names and that will help take a more scientific approach to comparing names,” Phillips says.

After drugs are approved, the FDA tracks reports of errors due to drug name confusion and spreads the word to health professionals, along with recommendations for avoiding future problems. For example, the FDA has reported errors involving the inadvertent administration of methadone, a drug used to treat opiate dependence, rather than the intended Metadate ER (methylphenidate) for the treatment of attention-deficit/hyperactivity disorder (ADHD). One report involved the death of an 8-year-old boy after a possible medication error at the dispensing pharmacy. The child, who was being treated for ADHD, was found dead at home. Methadone substitution was the suspected cause of death. Some FDA recommendations regarding drug name confusion have encouraged pharmacists to separate similar drug products on pharmacy shelves and have encouraged physicians to indicate both brand and generic drug names on prescription orders, as well as what the drug is intended to treat.

The last time the FDA changed a drug name after it was approved was in 2004 when the cholesterol-lowering medicine Altocor was being confused with the cholesterol-lowering medicine Advicor. Now Altocor is called Altoprev, and the agency hasn’t received reports of errors since the name change. Other examples of drug name confusion reported to the FDA include:

  • Serzone (nefazodone) for depression and Seroquel (quetiapine) for schizophrenia
  • Lamictal (lamotrigine) for epilepsy, Lamisil (terbinafine) for nail infections, Ludiomil (maprotiline) for depression, and Lomotil (diphenoxylate) for diarrhea
  • Taxotere (docetaxel) and Taxol (paclitaxel), both for chemotherapy
  • Zantac (ranitidine) for heartburn, Zyrtec (cetirizine) for allergies, and Zyprexa (olanzapine) for mental conditions
  • Celebrex (celecoxib) for arthritis and Celexa (citalopram) for depression.

Drug labeling: Consumers tend to overlook important label information on OTC drugs, according to a Harris Interactive Market Research Poll conducted for the National Council on Patient Information and Education and released in January 2002. In May 2002, an FDA regulation went into effect that aims to help consumers use OTC drugs more wisely.

The regulation requires a standardized “Drug Facts” label on more than 100,000 OTC drug products. Modeled after the Nutrition Facts label on foods, the label helps consumers compare and select OTC medicines and follow instructions. The label clearly lists active ingredients, uses, warnings, dosage, directions, other information, such as how to store the medicine, and inactive ingredients.

As for health professionals, the FDA proposed a new format in 2000 to improve prescription drug labeling for physicians, also known as the package insert. One FDA study showed that practitioners found the labeling to be lengthy, complex, and hard to use. The proposed redesign would feature a user-friendly format and would highlight critical information more clearly. The FDA is still reviewing public comments on this proposed rule. The agency also has been working on a project called DailyMed, a computer system that will be available without cost from the National Library of Medicine next year. DailyMed will have new information added daily, and will allow health professionals to pull up drug warnings and label changes electronically.

Error tracking and public education: The FDA reviews medication error reports that come from drug manufacturers and through MedWatch, the agency’s safety information and adverse event reporting program. The agency also receives reports from the Institute for Safe Medication Practices (ISMP) and the U.S. Pharmacopeia, or USP (see “Who Tracks Medication Errors?”).

A recent ISMP survey on medication error reporting practices showed that health professionals submit reports more often to internal reporting programs such as hospitals than to external programs such as the FDA. According to the ISMP, one reason may be health professionals’ limited knowledge about external reporting programs.

The FDA receives and reviews about 300 medication error reports each month and classifies them to determine the cause and type of error. Depending on the findings, the FDA can change the way it labels, names, or packages a drug product. In addition, once a problem is discovered, the FDA educates the public on an ongoing basis to prevent repeat errors.

In 2001, the agency released a public health advisory to hospitals, nursing homes, and other health care facilities about the hazards of mix-ups between medical gases, which are prescription drugs. In one case, a nursing home in Ohio reported four deaths after an employee mistakenly connected nitrogen to the oxygen system.

The ISMP reports medication errors through various newsletters that target health professionals in acute care, nursing, and community/ambulatory care. The ISMP also has launched a newsletter for consumers called Safe Medicine.

In December 2003, the USP released an analysis of medication errors captured in 2002 by its anonymous national reporting database, MedMARX. Of the errors reported to MedMARX, slightly more than one-third reached the patient and involved a geriatric patient. Many of these medication errors were found to be harmful.



4. Preventing Medication Errors

Medication Errors: Definitions and Classification
Jeffrey K Aronson

Classification of Medication Errors

The best way to understand how medication errors happen and how to prevent them is to consider their classification, which can be contextual, modal, or psychological. Contextual classification deals with the specific time, place, medicines, and people involved. Modal classification examines the ways in which errors occur (e.g. by omission, repetition, or substitution). However, classification based on psychological theory is to be preferred, as it explains events rather than merely describing them. Its disadvantage is that it concentrates on human rather than systems sources of errors. These classifications have been discussed in detail elsewhere.

Psychologists consider an error to be a disorder of an intentional act, and they distinguish between errors in planning an act and errors in its execution. If a prior intention to reach a specified goal leads to action, and the action leads to the goal, all is well. If the plan of action contains some flaw, that is a ‘mistake’. If a plan is a good one but is badly executed, that is a failure of skill.

Figure 2:
Preventing Medication Errors

This approach yields four broad types of medication error (numbered 1–4 in Figure 2). Mistakes can be divided into (i) knowledge-based errors and (ii) rule-based errors. Failures of skill can be divided into (iii) action-based errors (‘slips’, including technical errors) and (iv) memory-based errors (‘lapses’).

Knowledge-based errors can be related to any type of knowledge, general, specific, or expert. It is general knowledge that penicillins can cause allergic reactions; knowing that your patient is allergic to penicillin is specific knowledge; knowing that co-fluampicil contains penicillins is expert knowledge. Ignorance of any of these facts could lead to a knowledge-based error.

Rule-based errors can further be categorized as (a) the misapplication of a good rule or the failure to apply a good rule; and (b) the application of a bad rule.

An action-based error is defined as ‘the performance of an action that was not what was intended’. A slip of the pen, when a doctor intends to write diltiazem but writes diazepam, is an example. Technical errors form a subset of action-based errors. They have been defined as occurring when ‘an outcome fails to occur or the wrong outcome is produced because the execution of an action was imperfect’. An example is the addition to an infusion bottle of the wrong amount of drug.

Memory-based errors occur when something is forgotten; for example, giving penicillin, knowing the patient to be allergic, but forgetting.


This classification can help understand how errors can be prevented […]

Knowledge-based errors can obviously be prevented by improving knowledge, e.g. by ensuring that students are taught the basic principles of therapeutics and tested on their practical application and that prescribers are kept up to date. Computerized decision-support systems can also train prescribers to make fewer errors.

Mistakes that result from applying bad rules, or misapplying or failing to apply good rules (rule-based errors), can be prevented by improving rules.

Training can help in preventing technical (action-based) errors.

Memory-based errors are the most difficult to prevent. They are best tackled by putting in place systems that detect such errors and allow remedial actions.

Source: Aronson, Jeffrey K. Medication errors: definitions and classification


5. Reporting Medication Errors

Computer based medication error reporting: insights and implications
M R Miller, J S Clark, and C U Lehmann

Of the 1010 medication errors reviewed, 298 (30%) were prescribing errors, 245 (24%) were dispensing errors, 410 (41%) were administration errors, and 57 (6%) involved medication administration records (MAR). Following expert review, 208 errors (21%) were deleted because they had been inappropriately coded as errors and 97 (10%) were added as they were not initially coded despite having occurred. In addition, 352 medication error reports needed to have the subtype of error reclassified; 207 (59%) of these involved the reporter choosing the non‐descript “other” category on the reporting tool (such as “Prescribing other”) which was able to be reclassified by expert review. The overall distribution of error type categories did not change significantly with expert review, although only MAR errors were underreported by the reporters. The most common medications were anti‐infectives (17%), pain/sedative agents (15%), nutritional agents (11%), gastrointestinal agents (8%), and cardiovascular agents (7%).

Despite clear imperfections in the data captured, medication error reporting tools are effective as a means of collecting reliable information on errors rapidly and in real time. Our data suggest that administration errors are at least as common as prescribing errors in children. Further research is needed, not only in the area of computerized physician order entry (CPOE) for children, but also on ways to make the dispensing and administration of medications safer.

Source: M R Miller, J S Clark, and C U Lehmann. Computer based medication error reporting: insights and implications

5.1 Reporting Medication Errors

Concepts in Managed Care Pharmacy: Medication Errors
The Academy of Managed Care

Health care professionals and consumers have the opportunity to report the occurrence of
medication errors to a variety of organizations. Examples include the Institute of Safe
Medication Practices (ISMP) and the Food and Drug Administration (FDA). These
organizations collectively review error submissions. Case reports are published to educate health care professionals regarding errors and near errors. In some cases, the FDA may work with drug manufacturers and others to inform them about concerns with pharmaceutical labeling, packaging and nomenclature to make appropriate changes to reduce the risk of medication errors.

AMCP has voiced support for a medication error reporting system that encourages participation and provides confidentiality and protection of the information reported and the person(s) reporting. To be successful a medication error reporting system must have protections for those reporting. Often, pharmacists view mandatory reporting laws and regulations as punitive, especially if public disclosure is included. Compliance with such programs is likely to be less than optimal since the results of reporting could include lawsuits, regulatory enforcement actions, forfeiture of pharmacy license, and loss of professional reputation with accompanying loss of business.

Regulatory and advocacy activity provides for improving monitoring of medication errors. The FDA MedWatch reporting system provides a comprehensive sentry position for many
medication errors to be reported. Although designed primarily for reporting adverse events from medication use, FDA’s MedWatch is an appropriate venue to discover medication errors, such as prescribing misadventures and look-alike, sound-alike errors leading to adverse reactions. Many state boards of pharmacy have begun medication error reporting initiatives to detect trends in ambulatory dispensing errors. At this point in time, most are limited to mandatory internal reporting systems within a setting, as is the case in California, where errors must be logged and open for board inspection during routine visits and complaint investigation. Many physician boards and associations participate in prescribing error investigations, driven primarily by peer review and consumer complaint resolution.

Source: The Academy of Managed Care.

5.2  Detection & Audit

Prevention of medication errors: detection and audit
British Journal of Clinical Pharmacology
Germana Montesi and Alessandro Lechi


  1. Medication errors have important implications for patient safety, and their identification is a main target in improving clinical practice errors, in order to prevent adverse events.
  2. Error detection is the first crucial step. Approaches to this are likely to be different in research and routine care, and the most suitable must be chosen according to the setting.
  3. The major methods for detecting medication errors and associated adverse drug-related events are chart review, computerized monitoring, administrative databases, and claims data, using direct observation, incident reporting, and patient monitoring. All of these methods have both advantages and limitations.
  4. Reporting discloses medication errors, can trigger warnings, and encourages the diffusion of a culture of safe practice. Combining and comparing data from various and encourages the diffusion of a culture of safe practice sources increases the reliability of the system.
  5. Error prevention can be planned by means of retroactive and proactive tools, such as audit and Failure Mode, Effect, and Criticality Analysis (FMECA). Audit is also an educational activity, which promotes high-quality care; it should be carried out regularly. In an audit cycle we can compare what is actually done against reference standards and put in place corrective actions to improve the performances of individuals and systems.
  6. Patient safety must be the first aim in every setting, in order to build safer systems, learning from errors and reducing the human and fiscal costs.
Keywords: clinical audit, clinical risk management, incident reporting, medication error, patient safety

Medication errors and drug-related adverse events have important implications – from increased length of hospitalization and costs to undue discomfort and disability or increased mortality. Reason has proposed two approaches to considering errors and accidents. First, identify individual problems and deficiencies that can lead to error; second, analyse faulty systems design. Problems with both individuals and systems are responsible for most accidents. However, individual problems can also result from defective systems. The frequency and severity of medication errors are not evenly distributed in the population, and there are clusters of patients, drugs, and settings that are associated with higher risks; however, these can generally be attributed to common underlying contributory/latent factors.

[5.3]  Detection

In order to build safer systems we must be able to learn from previous errors, and detection is the first crucial step. Scientific societies and surveillance agencies, reviews, original studies, and case reports may warn us to be on the alert and promote knowledge of risks and improved performance. For this purpose, reports, alerts and recommendations are available on the web, issued by national and federal healthcare systems, regulatory agencies, and non-profit-making organizations [the Food and Drug Administration (FDA), European Medicines Agency (EMEA), United States Pharmacopeia (USP-MEDMARX), UK – National Health Service (NHS), Veterans Health Administration (VHA), Australian Patient Safety Foundation (APSF), Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)][78].

The approaches used to detect errors are likely to be different in research and routine care, given the available resources [9]. In order to prevent medication errors and reduce the risks of harm, organizations need tools to detect them [10]. Any system must then be able to analyse errors and identify opportunities for quality improvement and system changes. The major methods for detecting adverse events are chart review, computerized monitoring, incident reporting, and searching claims data. Medication errors are mainly detected by means of direct observation, voluntary reporting (by doctors, pharmacists, nurses, patients, and others) and chart review. Research applies combined methods. The advantages and limits of the main methods are summarized in Table 1; here are notes on the most interesting ones [1011].

[5.4] Chart review

Chart review is retrospective and based on practice sources (medical charts and laboratory data, prescription data, and administrative data). It can be improved by using computerized data, such as electronic medical records, computerized physician order entry (CPOE), and computer-integrated triggers. Chart review is the most precise approach for detecting adverse events, but is less good at detecting medication errors. Cases are evaluated independently by two or more experts. Good planning is required for definitions, inclusion criteria, and triggers. The downsides of this method are the difficulty in training reviewers (nurses, pharmacists, students, research assistants) and the resources needed, both fiscal and human. Furthermore, the results depend on the quality of documentation and reviewers’ abilities to capture triggers.

[5.5] Computerized monitoring

Computerized monitoring is the modern version of voluntary pharmacist reporting (pharmacy logs) [13]. Pharmacists detect order errors, rectify them, and fill out a report. Medication errors can thus be intercepted before adverse events occur. If CPOE is in use, prescription and dispensing errors may be readily detected [14]. Advanced software implementation supports integration of laboratory and clinical data with Clinical Decision Support Systems (CDSS), providing detection and prevention of adverse events. CPOE systems improve safety, but need to be used in combination with CDSS. Implementation of information technology is costly and necessary for safety, but it can also give rise to new, unknown risks.

[5.6] Administrative databases

Administrative databases screen International Classification of Diseases, 9th revision codes, for statistical purposes. Patient safety indexes and adverse event-adjusted rates are elaborated from a combination of discharge data. However, adverse events are poorly detected, because of the lack of clinical data.

[5.7] Claims data

The value of screening of claims data is limited by the underlying reasons for litigation, which are sometimes frivolous, and by the involvement of small numbers of local claims. Events often still need to be confirmed, and about one-third of claims lack evidence of errors. Claims data have a positive predictive value for adverse events of about 50%, of which only about 18% point to a medication source [15].


Direct observation is the only method available for detecting errors of administration of medications. A trained nurse observes drug administration, registers each action, and then compares what was done with the original physician orders. The observer must be trained and visits different units in sequence.


Reporting systems derive from procedures in high-reliability organizations. However, their application to health systems is quite difficult. Reports submitted to management or legal services can cause misunderstanding and carry a connotation of blame. Furthermore, reports may concern different organizations, according to the field of application, causing multiplication and incorrect analysis.

The Royal College of Anaesthetists was the first to use an incident reporting system in the UK in 1978. Nowadays, every health system requires reporting, either directly (the VHA in the USA, the Ministero della Salute in Italy), or by specific agencies [Australian Institute of Medical Scientists in Australia, National Report Learning System (NRLS) in the UK]. The Joint Commission in the USA (formerly the Joint Commission on the Accreditation of Healthcare Organizations) analyses reports from accredited care settings, and issues alerts and recommendations based on integrated data analysis. National Patient Safety Goals (NPSGs) are then elaborated, with subsequent practice suggestions and improved standards of quality to be fulfilled. In the UK the National Patient Safety Agency (NPSA) has developed the first comprehensive NRLS and has set up the Patient Safety Observatory to compare and combine data from the NRLS with other sources of information, such as litigation bodies, industry, healthcare organizations, and patients. Drug-related reports are also collected by specific surveillance agencies (USP-MEDMARX, FDA, EMEA, Italian Pharmaceutical Agency (AIFA)). Major organizations are now trying to integrate a wider database, as latent failures and system errors are widespread and often repetitive.

There are two safety-oriented levels of reports:

  1. Incident reporting Where this is in place, it is obligatory and restricted to severe unexpected events/deaths (sentinel event list). A timely narrative report of the incident must be sent, with root cause analysis, to the central organization, which issues regular statistical reports, capturing both adverse events and medication errors and raising concerns about quality improvement.
  2. Voluntary reporting Voluntary reporting must be anonymous, confidential, and blame-free. A simple structured form is required to help reporting and analysis. Feedback, regular reports, and the implementation of corrective actions are all necessary. Near misses and medication errors are usually reported, but rarely adverse events . An increasing number of reports does not necessarily betoken poor practice, but is related to improved capture of events. The advantages of voluntary reporting are the discovery of active and latent systems failures, evidence of the critical nature of processes, the correction of contributory factors, and the diffusion of a culture of safety. Every experience underlines the existence of common barriers to physician involvement in reporting of errors, in fact this is minimal compared with the nurses’ involvement [19]. Although the vast majority of incidents will be reported locally, the existence of another independent and confidential reporting system provides a safety net for staff.


Patient monitoring, with interviews, using structured forms, by mail, telephone, or visits, or by satisfaction questionnaires and focus groups, can discover medication errors and associated adverse events in outpatients [12], where many errors arise from poor communication. In future the focus will be on long-term care, primary care, and outpatients.


In 1854 Florence Nightingale used audit to prevent postsurgical mortality. In 1989, Working for Patients, a UK Government white paper, proposed standardization of audit as part of professional healthcare. The paper defined ‘medical audit’ as ‘the systematic critical analysis of the quality of medical care, including the procedures used for diagnosis and treatment, the use of resources, and the resulting outcome and quality of life for the patient.’

In a paper, Principles for Best Practice in Clinical Audit, published by the National Institute for Health and Clinical Excellence [20], multidisciplinary ‘clinical audit’ was proposed and defined as: ‘a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change’. The paper went on to say that ‘Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery’.

Clinical audit is generally retroactive, caused by the occurrence of near-miss events and adverse or critical events involving a multidisciplinary team. The team’s discussion is confidential, anonymous, and blame-free; its aim is to monitor critical events, revisiting care actually provided and learning for the future. Peer review is similar, but is concerned with ‘interesting’ or ‘unusual’ cases, rather than problematic ones. Recommendations from these reviewers are often not pursued, as there is no systematic method to follow. Users’ views about quality of care, when available, are evaluated.

Audit is also an educational activity, which promotes high-quality care and should be carried out regularly. It is characterized by the Deming cycle (Plan–Do–Check–Act; named after the US philosopher W. Edwards Deming, 1900–1993) and offers a systematic framework for investigating and assessing the work of healthcare professionals and for introducing and monitoring improvements. The audit process involves a characteristic sequence of events, the audit cycle:

  1. Planning the audit by identifying the problem, the objectives, the current state of the art, the participants (five to seven multiprofessional, interested people, a leader, a secretary), activities, responsibilities, times, limits, and resources.
  2. Defining objectives, standards, or protocols of best practice against which performance can be compared (evidence based medicine and nursing, scientific reviews, guidelines, benchmarking data, leaders’ opinions), and developing evaluation criteria for adherence to these standards and indicators; the standards, criteria, and indicators must be clear, written, and agreed [21].
  3. Gathering systematic and objective evidence of performance (according to stated criteria).
  4. Comparing the results with preset criteria and standards and/or among peers.
  5. Identifying deficiencies and solutions and planning implementation actions.
  6. Closing the loop by monitoring the results obtained and producing a report.

Clinical audit should be an objective way of measuring and monitoring practice against a set of agreed standards and of detecting mismatches between the written word and actual practice. Audit is not a means for measuring outcomes, but a way of comparing what we do against what research evidence indicates should be done – auditing performance against a reference standard [21]. Audit enables assessment of the appropriateness of specific healthcare decisions, services, and outcomes.

Change is possible when an intervention is well designed, and most quality interventions that have been studied have had some effect (average about 10% for main targets). However, none of them is superior for all changes in all settings. Interventions that are targeted at specific obstacles to change seem to be more effective than those that are not .

Audit and feedback seem to be effective when they target the ordering of tests and preventive activities, but the effect size can be modulated by feedback, depending on its source, format, and frequency or intensity of presentation. Feedback is recommended in combination with education, outreach visits, or reminders.

The audit process is better used in the USA, UK and Australia, where it has influenced clinical practice and management, changing the culture of healthcare providers, enabling them to appreciate written guidelines and protocols and to develop a sense of clinical accountability, interprofessional understanding, and sensitivity to patients’ needs. However, it has some drawbacks: it takes time and effort, it is resource intensive, and facilitators need to be trained.

Clinical audit can also be used proactively, in the hope of avoiding medication errors or adverse events that have not yet occurred, but have been outlined in surveillance alerts like JCAHO Sentinel Event Alert and National Patient Safety Goals (NPSGs), or in order to pay attention to a known critical step (for example, prescription dispensing forms, discharge therapy, oral anticoagulant prescription) .

To conduct proactive risk assessment the use of Failure Mode, Effect, and Criticality Analysis is recommended, in order to survey critical processes (e.g. cancer chemotherapy, potassium chloride infusion) [14]. It analyses all potential failure modes and consequent failure effects inside the system, as perceived by the user. A block diagram gives an overview of the major components of the steps in the process and how they are related. The process is mapped step by step, by subprocesses and activities, with their single possible failures. Risk analysis can be calculated by means of the Risk Priority Number (RPN) = Severity × Occurrence × Detectability. Failures can be prioritized according to the RPN, the highest being given the highest priority for corrective or preventive actions.


Prevention of medication errors relies on epidemiological knowledge, detection of errors, and improvements in performance.

Chart review is the gold standard in detecting adverse drug-related events and, in future, computerized monitoring will be the method of capturing adverse events before they occur.

Reporting discloses medication errors, can trigger warnings, and encourages the diffusion of a culture of safe practice.

Audit is a relatively simple tool for evaluating actual performance and in planning corrective actions to reduce the risk of medication errors.

Source: British Journal of Clinical Pharmacology. Volume 67, Issue 6, pages 651–655, June 2009.

National Medication Errors Reporting Program

The National Medication Errors Reporting Program
Institute for Safe Medication Practices (ISMP)

Please describe the adverse drug event, close call, or hazardous condition as best you can. Tell us the story of what went wrong, any causes or contributing factors, how the event was discovered/intercepted, and the outcome of the patient(s) involved.  Please share your recommendations for error prevention.

Other information to provide includes:

  • Type of practice site (e.g., hospital, private office, community pharmacy, clinic, manufacturer, long-term care facility).
  • The names of all products involved.
  • The dosage form, concentration or strength, etc.
  • Associated materials such as product photographs, containers, labels, prescription order scans, etc., that help support the information being submitted.

After you submit a report, an ISMP staff person will follow-up with you to ask additional questions to further clarify what went wrong as well as identify the causes and factors that contributed to the reported event.

Report Here.



Course TEST 6660: Click here for the self-correcting test  that requires 75% for a passing grade. (CA CEP 16144)

Recommendations for you: Visit our “Preventing Falls” course ( to learn about how big the fall problem actually is, outcomes linked to falls in the elderly, who is at risk, how can older adults prevent falls, how to maintain healthy bones, basic information on bone diseases, basic tips on fall prevention in children, and available resources and references.


2 thoughts on “Preventing Medication Errors

Leave a Reply