Concept Series:Medication errors are among the most common medical errors, harming at least 1.5 million people every year. The extra medical costs of treating drug-related injuries occurring in hospitals alone are at least to $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs, the report says.1 Medication error morbidity and mortality costs are estimated to run $77 billion dollars per year.2 Patient safety is a major public health concern. The Academy of Managed Care Pharmacy (AMCP) recognizes the importance of this issue and supports programs that help achieve the goal of improved patient safety and prevention of medication errors. AMCP’s Framework for Quality Drug Therapy,3 emphasizes and promotes public safety, continuous monitoring for accuracy in dispensing, reliability in the transmission of prescription and medication orders, and continuous review and upgrade of pharmacy operating systems. Show What are Medication Errors?The National Coordinating Council for Medication Error and Prevention (NCCMERP) has approved the following as its working definition of medication error: “... 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”. This concept paper focuses on the types of medication errors that take place in the ambulatory setting--that is, among patients who self-administer their medications, rather than those patients receiving medications in a clinic or hospital setting. The types of errors that occur in this environment differ from those that occur in institutional settings; this paper will not address the issues and efforts undertaken by pharmacy colleagues in those practice settings. How Do Medication Errors Occur? The provision of drug therapy by a medical provider to a patient is a complex process. Errors can occur at any step along the way, from prescribing to the ultimate provision of the drug to the patient. Common causes of medication error include incorrect diagnosis, prescribing errors, dose miscalculations, poor drug distribution practices, drug and drug device related problems, incorrect drug administration, failed communication and lack of patient education.4 One of the largest causes of therapeutic medication misadventures is incorrectly prescribed medication. The number of patient deaths resulting from drug errors has increased from 198,000 in 1995 to 218,000 in 2000. The cost of these misadventures to the US economy is more than $177 billion per year.5 Preventable errors occur because systems for safely prescribing and ordering medication are not appropriately used.
The term dispensing error refers to medication errors linked to the pharmacy or to whatever health care professional dispenses the medication. These include errors of commission (e.g. dispensing the wrong drug, wrong dose or an incorrect entry into the computer system) and those of omission (e.g. failure to counsel the patient, screen for interactions or ambiguous language on a label). Errors may be potential -- detected and corrected prior to the administration of the medication to the patient.6 The three most common dispensing errors are: dispensing an incorrect medication, dosage strength or dosage form; miscalculating a dose; and failing to identify drug interactions or contraindications. Errors caused by drug administration can be made by the health care provider or by the patient themselves. Much of the problem in drug administration is communication. Patients are often unaware that errors can happen and often do not take an active role in understanding what is being communicated to them. Errors most often occur when communication is unclear regarding: drug name, drug appearance, why the patient is taking the drug, how much and how often to take it, when is the best time to take it, how long to take it, what common side effects could occur, what to do about a missed dose, common interactions with other drugs or foods, and whether this new drug replaces or augments other therapy. Over-the-counter medications can lead to medication errors because labels may not be sufficiently read or understood, and health care providers are often unaware when patients are taking over-the-counter medications. The types of errors described above are primarily errors of commission. There are also errors of omission, such as the failure to administer a drug that was prescribed or not administering a drug in a timely manner. Although they are much more difficult to identify through systematic reporting tools, errors of omission must also be addressed through process improvement efforts in order to truly improve patient safety in a comprehensive manner. Attitudes About Medication Errors Medical professionals, including physicians, nurses and pharmacists, do not deliberately commit medication errors. They are trained to deliver “error free” health care. However, when errors are discovered, there is an attitude of placing “blame” on the professional(s) involved in the incident. Formal punishment by the individual’s profession is sometimes administered, resulting in fines, license suspension or even license revocation. More importantly, the individual may be punished by the lost respect of his or her fellow health care professionals, which may be even more devastating than a professional reprimand.7 Where medication errors are concerned, the question of who was involved is of less importance than what, how and why the system went wrong.8 An investigation of medication errors should begin with an analysis of the drug use and delivery channels within a health care system, rather than result in punitive action directly targeted to the health care provider involved with the error. Although there is no acceptable level of error within the medical care system, the goal of health care organizations should be to evaluate errors when they occur and to make changes in the drug delivery process to prevent them from reoccurring in the future or elsewhere. AMCP encourages all medical professionals to take responsibility in efforts to identify, monitor, evaluate and prevent medication errors, and believes that managed care organizations should establish a nonthreatening, non-punitive and confidential environment that encourages health professionals to report medication errors in a timely manner.9 Reporting Medication Errors 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.10 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.11 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. Managed Care Pharmacy and Medication Errors The vast majority of prescriptions filled in the United States are paid for and administered by managed care organizations. These organizations can influence health care providers and their professional societies as well as consumers to encourage medication error reporting and prevention. Quality improvement programs within managed care organizations include mechanisms for reporting medication errors, examining and evaluating causes of errors, analyzing aggregate data to determine trends and making necessary changes within their health care delivery system to prevent errors from occurring. Managed care has taken an active role in developing and adopting technologies and systems designed to curtail the number of medication errors. Managed care organizations provide tools including online drug utilization review and real-time prescription processing blocks when a medication is clearly inappropriate based on therapeutic duplication, medication dosage or drug interaction. Keys to Error PreventionPatient
Education
The responsibility for the prevention of medical errors rests not only with health care professionals and health care systems but also with the patients themselves. By being informed not only about the names of their medications but the reasons for their use, the times they should be administered and the correct dose, patients can act as the final check in the system. The practice of carrying a continually updated list of medications can be invaluable in the event of an emergency or if patients cannot speak for themselves. This reduces the chance of miscommunications or misinformation. When patients take an active and informed role in his or her health care, many errors can be prevented. Prior Authorization Bar Coding
Electronic Prescription Record E-prescribing Utilization of electronic prescribing by entering orders on a computer, better known as Computerized Physician Order Entry (CPOE), is a technology that could help prevent many medication errors. CPOE systems allow physicians to enter prescription orders into a computer or other device directly, thus eliminating or significantly reducing the need for handwritten orders. E-prescribing and CPOE can reduce medication errors by eliminating illegible and poorly handwritten prescriptions, ensuring proper terminology and abbreviations, and preventing ambiguous orders and omitted information.13 More advanced CPOE software incorporates additional safety features that allow the physician to have access to accurate patient information, including patient demographic information such as age, medication history and medication allergies. Electronic DUR
Automated Medication Dispensing Proactive system interventions also provide additional error prevention protection. Many pharmacies and commercial dispensing systems now provide messaging during the drug selection process. When a drug is known to be subject to look-alike, sound-alike drug name confusion, the dispenser is alerted to double check that the appropriate agent has been chosen. In many dispensing environments DUR responses and resolutions are reviewed by an overview process. When excessive overrides by a dispensing practitioner are detected, the overview process ensures that proper professional evaluation is being conducted to prevent errors such as those described in the previous DUR section. It is very important that reporting and all subsequent activities are properly evaluated by a continuous quality improvement (CQI) process. A constantly evolving work flow improvement procedure provides maximum safety and is not designed solely for punitive reasons. Increasing pressures from litigation and liability issues should be sufficient for any ambulatory pharmacy entity to establish practices that demonstrate there are diligent efforts underway to protect patients from harmful medication errors. ConclusionIn summary, medication errors are an unfortunate part of the health care delivery system. Health care provider attitudes must change in the approach to prevention of these errors. Patient education is an important aspect of any program to prevent medication misadventures. Organizations such as ISMP, and the FDA, as well as individual managed care organizations can help to evaluate the cause of medication errors. The collection of error data and analysis in the health care delivery process will minimize the risk of medication errors and improve patient safety. The health care community must recognize that both people and systems contribute to medication errors. The focus should be on identifying the error-prone aspects of the medication use continuum with the goal of improving system safety and reliability through remedial action. Neither committing nor reporting an error should become the basis for disciplinary or punitive action by an employer.16 Every error should be examined to determine what elements in the system allowed it to happen. In this way, those who manage health systems can learn from error and determine what corrections are needed to prevent similar errors in the future. Medication error reduction programs are necessary to achieve improvement in patient care and to satisfy the public demand for a safer health care system. Consumers expect a system of high integrity that will serve them well and not be a cause for peril when health care is needed. They want and deserve to be confident in the safety of the health care system. Those who pay for health care services (government, employers and individuals) would benefit from a reduction in costs that would result from the reduction in adverse events associated with medication errors. 1 Institute of Medicine, Committee on Identifying and Preventing Medication Errors, Preventing Medication Errors. National Academies Press; 2007:124-25. 2 Matthew C. Grissinger, et al., "The Role of Managed Care Pharmacy in Reducing Medication Errors," Journal of Managed Care Pharmacy 9, no. 1 (2003): 62-65. 3 Academy of Managed Care Pharmacy, AMCP’s Framework for Quality Drug Therapy, http://www.fmcpnet.org/index.cfm?p=132D8447 (accessed February 17, 2010). 2 Matthew C. Grissinger, et al., "The Role of Managed Care Pharmacy in Reducing Medication Errors," Journal of Managed Care Pharmacy 9, no. 1 (2003): 62-65. 3 Academy of Managed Care Pharmacy, AMCP’s Framework for Quality Drug Therapy, http://www.fmcpnet.org/index.cfm?p=132D8447 (accessed February 17, 2010). 4 Cohen Michael R., Medication Errors, 2nd edition. (Washington, DC: American Pharmaceutical Association, 2007), 55-66. 5 Wendel Erin. Pharmacists Survey Gives Insight into the Impact of the Economic Downturn on Patients, Pharmacy Practice, and their Communities. Journal of the American Pharmacists Association, March 24, 2009. http://www.pharmacist.com/AM/Template.cfm?Template=/CM/ContentDisplay.cfm&ContentID=18987 (Accessed February 16, 2010). 6 Cohen, 205-234 7 Cohen., 1.4 8 Cohen, 4.55 9 Academy of Managed Care Pharmacy, Policy Digest: Recommendations to Reduce Medication Errors (2006). 10 Institute for Safe Medication Practices, The USP-ISMP Medication Errors Reporting Program. https://www.ismp.org/orderforms/reporterrortoismp.asp (March 18, 2010). 11 Academy of Managed Care Pharmacy, Where We Stand: Confidentiality and Protection of Medication Error Reporting. http://www.amcp.org/amcp.ark?p=AA39F78E (accessed March 18, 2010). 12 National Coordinating Council for Medication Error Reporting and Prevention, Recommendations for Bar Code Labels on Pharmaceutical (Drug) Products to Reduce Medication Errors, June 5, 2007. http://www.nccmerp.org/council/council2007-06-05.html (accessed February 16, 2010). 13 Cohen, 196. 14 Academy of Managed Care Pharmacy, Concepts in Managed Care Pharmacy Series: Drug Use Review. http://www.amcp.org/amcp.ark?p=AAAC630C (accessed March 18, 2010) 15 American Society of Consultant Pharmacists, White Paper on Automation in Pharmacy, 1998. 16 Cohen, 613 17 Academy of Managed Care Pharmacy, Where We Stand: Confidentiality and Protection of Medication Error Reporting. http://www.amcp.org/amcp.ark?p=AA39F78E (accessed March 18, 2010). What is the use of an unapproved drug called?Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer.
What does it mean if a medication is not FDA approved?Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.
Can a doctor prescribe something that is not FDA approved?Although the FDA approves all prescription drugs sold in the United States, the agency can't limit how doctors prescribe drugs after they're on the market. Doctors often direct patients to take medications for conditions that have not been approved by the FDA. This is called off-label drug use.
When a medical is not FDA approved what is it call trial?Drugs that are being tested but are not yet approved are called investigational (or experimental) drugs and patients can get access in two ways: They can participate in the drug testing process, known as a clinical trial, or.
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