Maria Grazia Allegretti
Medication Management Unit
Chief Medical Officer
Santa Chiara Hospital
Patient safety has become an international priority, especially after publication by the Institute of Medicine, in 1999, of the report To err is human: building a safer health system,(1) which identified the seriousness of the problem.(2) One of the major threats to patient safety in hospitals is represented by the occurrence, clinical consequences and cost of adverse drug events (ADEs), defined as injuries resulting from medical intervention related to the administration of a drug.(3) A medication error (ME) is, according to the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP),(4) any preventable event that may cause or lead to inappropriate medication use or patient harm. Such events may be related to professional practice, healthcare products, procedures and systems, including: prescribing; order communication; product labelling; packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.(5) The epidemiology of ME in hospitals(6) is the tip of the iceberg: reported MEs are only a small fraction of what really happens, and MEs are estimated to occur in nearly one of every five doses of the typical site (20%).(7) MEs occur every day, and during any phase of the drug delivery process, from prescribing to drug administration. Errors resulting in preventable ADEs occurred most often at the stages of ordering (56%) and administration (34%), with transcription (6%) and dispensing (4%) errors being less common.(8) The percentage of errors rated potentially harmful is a small fraction of this number, but although death or serious injury occurs only infrequently, MEs that have such results shake the foundation of public confidence in healthcare and increase healthcare costs. Among other organisations, the Joint Commission International (JCI) has adopted patient-safety goals as part of the accreditation process, and accredited hospitals are reporting data on the quality of care, including the prevention of MEs.(9) The JCI requires healthcare organisations to develop a process for identifying and reporting MEs. The goal of error reporting is to understand the kind of errors that occur in an organisation and to redesign processes to prevent similar errors in the future.(10)
It is generally agreed upon that effective risk management depends crucially on establishing a reporting culture that makes it possible to learn from detailed analysis of mishaps, incidents and near-misses. Physicians and nurses in general oppose reporting of information on medication errors, because of a “name, blame and shame” culture, and because of worries about malpractice lawsuits. Nonetheless, the greater use of information technology (ie, the use of solutions such as computerised order entry systems, barcoding of medication or electronic prescribing) and strategies for sharing information have the potential to make care safer and, therefore, reporting of errors must be strongly encouraged.(11)
The Hospital of Trento (HT; Italy) is part of the Health Care Trust–APSS, a very complex organisation of the National Health System, with a workforce of 7,000 employees, 11 primary care districts, and two hub and five spoke acute hospitals. HT is the main healthcare facility of the APSS and has the following characteristics: 874 beds (of which 110 are day hospital beds), approximately 38,000 admissions in 2004, about 2,000 employees (including 335 physicians) and cost of production up to €217,000,000. HT is accredited by JCI and provides a full range of medical and surgical services, including three intensive care units and all major specialties.
The process of medication management has been examined according to the JCI accreditation model. MEs are reported through a process and timeframe defined by the organisation (standard COP.11.6.3); the organisation’s leaders identify key measures (indicators) to monitor the organisation’s clinical and managerial structures, processes and outcomes (QPS 3), and clinical monitoring includes the use of antibiotics and other medications and medication errors (QPS 3.4).
The hospital Quality and Patient Safety (QPS) Committee has adopted a procedure to identify and report MEs related to any stage of the highly complex medication process, including prescribing, preparing, administering and monitoring of therapeutic effects. Reporting of MEs, based on the conceptual frame of the Failure Mode and Effect Analysis (FMEA) model and Ishikawa fishbone diagram, is strictly confidential and anonymous. Reporting of ME is gathered using a form (see Figure 1) divided into four sections:
- Medication system process phase when error occurred.
- Professionals involved.
- Error outcome category.
- Organisational conditions under which the error occurred.
It is possible to report more than one ME in a single form. Caregivers fill out the form by checking boxes to indicate the stage in which the error occurred (prescribing, preparing or administering), the type of error, who made the error and who detected it (by role only, no names are used), and where and when it occurred. Users classify the outcome related to ME using the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Medication Errors. According to NCC MERP, error outcome has been divided into four main categories:
- Circumstances or events that could have caused an error (A).
- Error with no harm (B, C, D).
- Error with harm (E, F).
The form also allows users to report circumstances that may have contributed to the error and make additional observations. The form, available through the hospital intranet, has been approved by the pharmacist (member of the QPS Committee) with specific meetings in the units.
The error reporting form is only filled out by the person who detected the error; completed forms are then reviewed and signed by both the head nurse and the director of the unit in which the error occurred. Ultimately, all reports are sent to Pharmacy; six-month summary reports are submitted to the QPS Committee and to HT units.
The new reporting system was been introduced to staff by early 2005. At the time of writing, several HT units have sent to Pharmacy a total of 289 forms with 353 MEs, split by type of error, shift and outcome.
Regarding the medication system phase during which errors occurred, 189 MEs (53.5%) were related to the prescription phase, 37 MEs (10.4%) to the preparation phase and 127 MEs (35.9%) to the administration phase. The most common causes of medication error were incomplete prescriptions, illegible writing and failure to administer a prescribed drug (see Figures 2 and 3). Error outcome category shows that the majority of MEs caused no harm: 113 (39.1%) of MEs were in the A category; 54 (18.7%) in the B category; and 54 (18.7%) in the C category (see Figure 4). Only 23 out of 289 forms showed an ME that caused temporary harm.
The reporting system yielded important information about the relationship between MEs and time of day. While the majority of MEs (163/353, 46%) occurred during the morning shift when most of the tasks are performed, the nightshift appears to be more high risk in terms of the ratio of errors to total prescriptions/administrations carried out.
According to these findings, most MEs had no actual adverse impact on patients, and no permanent patient harm was reported.
Efforts to introduce the reporting system ran up against a few cultural obstacles among clinical staff, due not only to resistance to change but also to fear of local laws and regulations requiring mandatory reporting of adverse events with harm.
To overcome these obstacles, the project team turned to education, and Pharmacy conducted several meetings with clinical staff to explain the new system. The no-blame approach helped in overcoming resistance and fostered a team-based approach to medication safety. Legal concerns were dealt with by clarifying that near-miss reports with no actual harm did not need to be communicated to public authorities.
ME reporting and monitoring should lead to performance improvement initiatives to address the causes of errors and prevent future events. At HT, the findings generated through the error reporting system have reinforced the need for several medication safety initiatives. The hospital recently implemented a new medication and administration record that reduces transcriptions and hand‑over and supports order verification. The hospital is also continuing its efforts to implement computerised physician order entry (CPOE) and automated medication distribution (AMD) systems throughout the organisation.
The project team plans to provide feedback to individual departments on their use of the system, conduct audits of system processes, provide updates on new safety procedures, and generally focus on continuous education in safety and risk reduction because, while processes are important, people are also a key to success.
The reporting system, which is strictly confidential, uses a systemic approach based on the consideration that, since humans are fallible, we should try to change the conditions under which people are working with a no-blame approach that makes it possible to learn from errors.(12) Since the causal factors of consequential incidents with harm are similar to those of non-consequential near-misses, we believe that knowing what happened can improve the effectiveness of preventive measures. The focus on medication use system and ME reporting helped the awareness of staff on the possible consequences of their daily actions.
- Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000.
- Battles JB, Lilford RJ. Organizing patient safety research to identify risks and hazards. Qual Saf Health Care 2003;12 Suppl II:ii2-7.
- American Society of Health-System Pharmacists. Suggested definitions and relationships among medication misadventures, medication errors, adverse drug events, and adverse drug reactions. Available from: http://www.ashp.com
- National Coordinating Council for Medication Error Reporting and Prevention. About medication errors. Available from: http://www.nccmerp.org
- Joint Commission Resources. Preventing medication errors: strategies for pharmacists. Oakbrook Terrace, IL; 2001.
- Bobb A, Gleason C, Husch M, et al. The epidemiology of prescribing errors. Arch Intern Med 2004;164:785-92.
- Barker K, Flynn E, Pepper GA, et al. Medication errors observed in 36 health care facilities. Arch Intern Med 2002;162:1897-903.
- Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implication for prevention. JAMA 1995;274:29-34.
- Joint Commission International. Joint Commission International Accreditation Standards for Hospitals. 2nd ed. Oakbrook Terrace, IL; 2003.
- Weissman J, Annas C, Epstein AM, et al. Error reporting and disclosure systems. JAMA 2005;293:1359-66.
- Altman D, Clancy C, Blendon RG, et al. Improving patient safety – five years after the IOM Report. N Engl J Med 2004;351:2041-3
- Reasons J. Human error: models and management. BMJ 2000;320: 768-70.