Authority Abu Dhabi Health هيي ة الصحة - أبوظبي Division/Department/Section: PHP/PHM Subject: Reporting Medication Errors. Reference Number: PHP/PHM/P0002/09 Issue Date: May 2009 Revision Date: May 2011 Version: 1 1. PURPOSE The purpose of the policy is to provide guidance for the health care professionals to take responsibility in medication error detection, reporting, evaluation, and prevention. The policy also intends to delineate specific measures that should be adopted by healthcare providers for promoting the development and use of a continuous quality improvement (CQI) system to detect and document, evaluate, report, and prevent medication errors..2. POLICY STATEMENT 2.1 Health Authority Abu Dhabi (HAAD) mandates all health care providers to develop organizational policies and procedures for tracking, identifying, documenting and reporting medication errors to HAAD. 2.2 Medication errors (see appendix 1) originating in all stages of medication use process should be reported, especially which are during: a) Writing of the prescription order b) Filling the order in the pharmacy c) Preparing the medication dose at the nursing station, or d) Administering the medication at the patient's bedside. 2.3 Errors that have been detected and corrected through intervention by another health care professional or patient, before actual medication administration should also be reported. 2.4 Health care professionals should adopt the standard Medication Error Severity categorization as detailed in Appendix 2 to document medication error severity in order to facilitate better management of follow up activities upon detection of the medication error. 1
2.5 Medication errors of severity level category G, H and I (see appendix 2) should be reported within 24 hours of identifying and documenting the error. All other errors (severity level category A to category F) should be reported on a monthly basis to HAAD. 2.6 Health care providers should continuously monitor actual and potential errors and investigate the root causes of errors to identify the ways of improving the medication use process to prevent future errors and patient harm. 2.7 Using the principles of formulary system, a Pharmacy and Therapeutic Committee (or its equivalent) composed of physicians, pharmacists, nurses and other health care professionals should be established in all organized health care settings to be responsible for formulating policies regarding medication error prevention, evaluation and therapeutic use of drugs. 2.8 It is imperative for the institutional pharmacies and community pharmacies under common control or ownership to develop quality assurance programme aimed at monitoring, tracking and evaluating medication errors. The pharmacy should also develop and follow procedures designed to prevent recurrences and periodically submit medication error reports to HAAD as per the time frame outlined in the policy. 2.9 Any information related to the identity of the patient and/or the reporter of the ME will be protected to the fullest extend of law and will not be used in any way against him. 3. APPLICABILITY The policy is applicable to all health care providers (private and public) in the Emirate of Abu Dhabi. 4. RESPONSIBILITY 4.1 It is the responsibility of all health care professionals and health facility management to comply with the requirements of the policy. 4.2 HAAD to monitor the compliance of ME reporting by health care providers through regular audit and inspection visits. 5. PROCEDURE 5.1 The HAAD Pharmacovigilance Center will oversee the reporting of all medication errors within the Emirate of Abu Dhabi. 5.2 All reporting should be made in the ME reporting form. (see Appendix 3). The ME reporting form is made available by HAAD to all health care facilities (private and public) in the Emirate of Abu Dhabi. It is the responsibility of the health care facility management to ensure the availability of the concerned ME forms in their facilities. The reporting form can also be accessed electronically via http://www.health.ae/pdic, and is also available from HAAD Pharma/ Medicines and Medical Products Department. 2
5.3 Applicable sections of the ME reporting form should be filled in as complete as possible. A separate form should be used for each patient and additional pages may be attached if more space is required. If more than one patient was affected by the same medication error, multiple reports for the same incident must be completed and submitted. 5.4 The completed ME reporting form may be submitted directly to HAAD Pharmacovigilance centre or forwarded electronically via email or by fax (Please see contact information below). HAAD will acknowledge the receipt of medication error reports by fax and / or email. Any follow up for an already reported ME case should be made by mentioning the unique report number provided in the acknowledgement letter. 5.5 The Pharmacovigilance Center will perform in depth analysis of the individual reports with the goal of identifying common causal factors. Based on the findings, HAAD will develop an established mechanism for tracking and identifying drugs or drug class that are commonly involved in medication errors. 5.6 Related facts that will be determined and documented by the Pharmacovigilance Center include what happened, where the incident occurred, why the incident occurred, how the incident occurred and who was involved. Correlation between errors and the current drug prescribing, filling, dispensing, administering and distribution practices (unit dose, floor stock, or bulk medications; premixed or extemporaneously compounded products; and oral or injectable products) etc. will also be reviewed. 5.7 Regulatory agencies and manufacturers are notified of needed changes in products when safety is of concern. If necessary, appropriate product evidence (packaging and labeling) will be retrieved and retained for future reference HAAD will also propose corrective measures on organizational system changes and individual practice changes, as necessary, to prevent medication errors in future. It will also collaborate with health care facilities to develop and implement best practices / non punitive actions and regulations that are aimed to promote patient safety and medication error reduction. 5.9 For more information on ME reporting, additional copies of ME reporting forms or to report a ME, health care providers, professionals and patients are invited to contact the following address through any of their preferred means: Health Authority Abu Dhabi Pharma /Medicines and Medical Products Department. Pharmacovigilance Center. Phone: 02 4193 586, 348, 580. Fax: 02 449 6679 Email:pv@haad.ae. 6. DEFINITION AND ABBREVIATIONS 3
HAAD Health Authority Abu Dhabi. ME Medication Error Medication Error A Medication Error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including: prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. Potential Error Errors that have been detected and corrected through intervention by another health care professional or patient, before actual medication administration. Non punitive actions Non punitive action means there will be no disciplinary action taken against an employee for a medication error that is reported as per the time frame outlined in the policy. Under this policy, nothing will be placed in the employees permanent employee record or used during the performance appraisal process. Continuing education, remedial training or an individualized action plan is not considered punitive or disciplinary action. Any information gathered through audits of medical records, intentional acts by the employee, (ie not an error or not the result of negligence ), wrongful / unlawful consumption of medications / controlled substances by the employee making the error, employees who knowingly fail to report a medication error are considered exceptions to Non punitive actions. 7. CROSS REFERENCES 4
1. National coordination council for Medication Error Reporting and Prevention: Also available at http://www.nccmerp.org/. Accessed on September 2008. 2. Addressing Medication Errors in Hospitals: California Health care foundation. Also Available at http://www.chcf.org Accessed on September 2008. 3. US Food and Drug Administration, Medication Errors. Available at http://www.fda.gov. Accessed on September 2008. 4. The Institute of Safe Medication Practices. Available at http://www.ismp.org. Accessed on September 2008. 5. Patient safety work shop Learning from Error. WHO publications document. WHO /IER/PSP/2008.09. 6. Preventing Medication Errors. Zellmer W. A. Am.J. Hosp Pharm 1990;47:1755 6 7. ASHP guidelines on preventing Medication Error in hospitals. Also available at www.ashp.org. Accessed on September 2008. 8. USP Medication Errors reporting Programme. Also available at www.usp.org. Accessed on September 2008. 9. World Alliance for patient safety. WHO draft guidelines for adverse event reporting and learning systems. WHO Publications document 2005. 5
8. APPENDIX Appendix 1 Types of Medication Errors Type Prescribing error Omission error Wrong time error Unauthorized drug error Improper dose error Wrong dosage form error Wrong drug preparation error Wrong administration technique error Deteriorated drug error Monitoring error Definition Incorrect drug selection(based on indications, contraindications, drug allergies etc), dose, dosage form, quantity, route, concentration, rate of administration, or instructions for use of drug product ordered or authorized by physician (or other legitimate prescriber), illegible prescriptions or medication orders that lead to errors that reach the patient. The failure to administer an ordered dose to a patient before the next scheduled dose, if any Administration of medication outside a pre defined time interval from its scheduled administration time (this interval should be established by each individual health care facility) Administration to the patient of medication not authorized by a legitimate prescriber for the patient. Administration to the patient of a dose that is greater than or less than the amount ordered by the prescriber or administration of duplicate doses to the patient ie one or more dosage units in addition to those that were ordered. Administration to the patient of a drug product in a different dosage form than ordered by the prescriber Drug product incorrectly formulated or manipulated before administration Inappropriate procedure or improper technique in the administration of a drug. Administration of a drug that has expired or for which the physical or chemical dosage form integrity has been compromised Failure to review a prescribed regimen for appropriateness and detection of problems, or failure to use appropriate clinical or laboratory data for adequate assessment of patient response to prescribed therapy Compliance error Other medication error Inappropriate patient behavior regarding adherence to a prescribed medication regimen Any medication error that does not fall into one of above defined categories. 6
Appendix 2 Medication error severity Classification Category A Circumstances or events that have the capacity to cause error Category B Category C Category D Category E Category F Category G Category H Category I An error occurred but the error did not reach the patient An error occurred that reached the patient but did not cause patient harm An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and /or required intervention to preclude harm. An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention. An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization. An error occurred that may have contributed to or resulted in permanent patient harm An error occurred that required intervention necessary to sustain life. An error occurred that may have contributed to resulted in patient death. Harm: Impairment of physical, emotional or psychological function or structure of the body and /or pain resulting there from. Monitoring: To observe or record relevant physiological or psychological signs. Intervention: May include change in therapy or active medical /surgical treatment. Intervention necessary to sustain life: includes cardiovascular and respiratory support as (e.g. defibrillation, CPR, intubation, etc.). Appendix 3 ME Reporting form 7
Appendix 3 8
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