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
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
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.
||Circumstances or processes that have the potential to
cause an adverse drug event.
||An event occurred but the patient was not harmed.
||An event occurred that resulted in the need for increased
patient assessments but no change in vital signs and no
||An event occurred that resulted in the need for treatment
and/or intervention and caused temporary patient harm.
||An event occurred that resulted in initial or prolonged
hospitalization, affected patient participation in an
investigational drug study, and/or caused temporary patient
||An event occurred that resulted in permanent patient
harm or near death event, such as anaphylaxis.
||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
- There is reason to believe criminal activity or criminal
intent may be involved in the making or reporting of an
- 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
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
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."
PROCEDURES AND RESPONSIBILITIES
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
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
ADR's are further
evaluated to determine:
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
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
Minutes are distributed
to the Safety Committee, P&T Committee Chair and Nursing
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
ADE Report and Review forms
7.0 QUALITY ASSESSMENT
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