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ISMP Medication Safety Alert


Medication Safety Contest Winner
policy for a non-punitive, system-based error reporting program
Frederick Memorial Hospital in Frederick, MD

Adverse Drug Events and Potential Adverse Drug Events These guidelines are intended to assist in the delivery of patient care or management of hospital services. They are not intended to replace professional judgment.

To provide a standardized mechanism for identifying, reporting, and monitoring medication errors and adverse drug events (ADES) and to provide a consistent mechanism for improving the medication use process.

This policy applies to medication therapy for all patients cared for in hospital departments and main campus outpatient services regardless of where the medication was originally prescribed.

Adverse Drug Event (ADE) - a deviation in the medication use process (prescribing, dispensing, administering, monitoring) OR undesirable clinical manifestation that is consequent to and caused by the administration or omission of medications.

Potential Adverse Drug Event (PADE) - a hazardous situation that could lead to an error. Adverse Drug Reaction (ADR) - is a subset of ADEs that includes any clinical manifestation that is undesired, unintended, or unexpected that is consequent to and caused by the administration of medications.

Preventable ADR - An ADR that resulted from a deviation in the medication use process that could be reasonably anticipated based upon existing policies and procedures, patient data, medical literature or accepted medical practice.

Medication Safety Improvement Committee - a subcommittee of the Pharmacy and Therapeutics Committee that reviews errors, trends, and significant ADEs/PADEs, and makes recommendations for system-based changes to improve the medication use process.

ADE/PADE Hotline - phone line to report possible ADEs.

ADE/PADE Report Form - Form completed by any member of FMH staff to document a possible ADE.

ADE/PADE Review Form - Form used by staff (with assistance of ADE/PADE Reviewers at tiems) to identify causative factors in preparation for entry into data base.

ADE/PADE Reviewer - Member of clinical staff (pharmacist, nurse, radiology technologist, respiratory therapist, physician) appointed by the P&T Committee who reviews/assesses reported ADEs/PADEs, assists staff with documentation, and serves on the Medication Safety Improvement Committee.

Clinical Interventions - Routines in the Pharmacy computer system that allows pharmacists to document interventions made to clarify or optimize medication therapy, such as, dosage adjustments, or nonformulary requests.

  Category 1: Circumstances or processes that have the potential to cause an adverse drug event.
  Category 2: An event occurred but the patient was not harmed.
  Category 3: An event occurred that resulted in the need for increased patient assessments but no change in vital signs and no patient harm.
  Category 4: An event occurred that resulted in the need for treatment and/or intervention and caused temporary patient harm.
  Category 5: An event occurred that resulted in initial or prolonged hospitalization, affected patient participation in an investigational drug study, and/or caused temporary patient harm.
  Category 6: An event occurred that resulted in permanent patient harm or near death event, such as anaphylaxis.
  Category 7: An event occurred that resulted in patient death.

The hospital encourages reporting of errors, adverse drug events, and potential adverse drug events as a means to assess and improve the medication use process and provide a safe environment for patient care. The purpose of the reporting errors is to learn about their causes and enhance the medication system to make it difficult for practitioners to err. Practitioners involved in medication use are required to participate in the detection and reporting of errors, the identification of the system-based causes of errors, and the facilitation of system enhancements to reduce the likelihood of errors. Thus, the focus of the program is quality improvement, not punishment. The hospital assumes that practitioners are doing their very best and that errors and ADEs are not the result of incompetence or misconduct. Therefore, employees are not subject to disciplinary action when making or reporting errors except in the following circumstances:

  • The employee consistently fails to participate in the detection, reporting, and the system-based remedies to prevent errors.
  • There is reason to believe criminal activity or criminal intent may be involved in the making or reporting of an ADE.
  • False information is provided in relation to the ADE/PADE report or investigation. The reporting program is coordinated through the Pharmacy and Therapeutics Committee, as part of the hospital's performance improvement and peer review function, with participation by Nursing and Pharmacy departments and the medical staff.

Pharmacy and Therapeutics reviews monthly ADE/PADE reports and recommendations by the Medication Safety Improvement Committee.

Pharmacists report ADRs to the FDA if they are serious, associated with a new drug, or not mentioned in the drug's labeling.

ADEs/PADEs are reported by physicians, nurses, pharmacists, patients, medical records/QA personnel or any member of hospital staff.

To report an error, an ADE/PADE Report Form is completed or a call is made to the ADE Hotline within 24 hours of the event's identification.

Staff members identifying an ADE in category 6 or 7 or classified as a sentinel event report the event, contact the Administrator on call and follow the steps outlined in the Sentinel Event Policy and Procedure. A root cause analysis is conducted in these cases as outlined in the Procedure for Conducting a "Root Cause Analysis."


5.1 Identifying an ADE
   5.1.1 Staff who suspect an ADE notify prescriber immediately if the event is significant or may alter the patient's plan of care.
   5.1.2 Staff assess the patient.
   5.1.3 Staff collaborate with clinical and supervisory resource personnel if unsure how to proceed
   5.1.4 Staff implement adjustments in patient's treatment as ordered.
   5.1.5 Staff document the factual description of the ADE, notification of physician and subsequent monitoring in the progress record.
5.2 Reporting an ADE
   5.2.1 Staff calls the ADE hotline, completes the ADE reporting form or enters an ADE clinical intervention in the Meditech Pharmacy-module within 24 hours of the ADE identification.
ADE forms are mailed, confidentially, to the Saf-Med Committee in the Pharmacy or put in an ADE drop box.
Pharmacy staff take ADE reports off Hotline 7 days a week and complete ADE Report forms. ADE's are entered as clinical interventions.
   5.2.2 Security of Information
       No copies are made of the ADE forms
       Clinical interventions are migrated into a secure data base
       Forms and data are secured in the Pharmacy and accessed by key or password.
5.3 Reviewing ADEs
   5.3.1 Supervisor/manager completes timely evaluation of the circumstances surrounding the event.
   5.3.2 ADE Reviewers assess all reports, to verify and collect additional data, and assign severity level.
       In the case of significant ADE's or medication-related sentinel events, reviewers confirm notification of department director or manager, as well as compliance with sentinel event policy (see 4.5 above).
   5.3.4 ADE reports are reviewed using published criteria and categorized by: location, severity, product information and therapeutic classification, type, causes and contributing factors.
       ADR's are further evaluated to determine:
       - Appropriateness of medication for patient's condition
       - Predisposing contraindications to medication         - Appropriate documentation of allergies
       - Appropriate management and monitoring of ADR
5.4 Trending/Reporting/Improving the Medication Use Process
   5.4.1 The Pharmacy Department performs the data entry, trending, and report distribution.
       The Pharmacy prepares a monthly analysis of ADE's
   5.4.2 The Pharmacy forwards monthly ADE trending reports to FMH managers. Managers are responsible for analyzing their department data and responding with performance improvement activities.
   5.4.3 ADEs are tabulated monthly and reported to the Saf-Med Committee. Reports include ADE and ADR rate.
   5.4.4 The Saf-Med Committee reviews the monthly report, significant events, results of root cause analysis and completion of consequent recommendations and makes recommendations for improvements to the medication use process.
Saf-Med Committee reports and recommendations are made to the P&T Committee.
       Minutes are distributed to the Safety Committee, P&T Committee Chair and Nursing management.
       P&T Committee recommendations are forwarded to the QACC.
   5.4.5 Medication use improvements and recommendations are communicated to FMH staff via e-mail, P&T minutes, Pharmacy Newsletter, educational offerings at medical staff and other department meetings.
ADE Report and Review forms
ADE reports are trended monthly and reviewed at the Pharmacy and Therapeutics Committee and Saf-Med Committee. The Committees make recommendations on surveillance, formulary changes, educational efforts, and policy changes as necessary.
Adverse reactions that occur following the administration of investigational drugs are reported according to the specific protocol for that drug by contacting the principle investigator. A probationary employee may be terminated if basic competencies related to the medication use process are not demonstrated.
Preparing the Pharmacy for a Joint Commission Survey, 4th Ed., Charles P. Coe, 1998 ASHP practice guidelines, 1999
NCC MERP Taxonomy of Medication Errors, 1998
Sentinel Events, FMH Housewide Manual, PI.111, 6/99
Procedure for Conducting a "Root Cause Analysis" (RCA), FMH Housewide Manual, PI.112, 6/99
Discipline Process, FMH Housewide Manual, HR.510, 3/99
Medication System Analysis Policy and Procedure, Chesapeake General Hospital, 1997 medication Error and Adverse Drug Event Policy, Newton-Wellesley Hospital, 2000
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