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Adverse Drug Event Documentation (8.20)

Adverse Drug Event Documentation (8.20) - Policies, Clinical, UWHC Clinical, UWHC-wide, Patient Care


As of January 1, 2017, this policy applies to the operations and staff of legacy UWHC. Effective July 1,
2015, the legacy operations and staff of UWHC and UWMF were integrated into the University of
Wisconsin Hospitals and Clinics Authority (UWHCA). All policies are being transitioned to apply
UWHCA-wide, but until future revision to this policy #8.20, it applies only to the operations and staff of
legacy UWHC.

8.20 Adverse Drug Event Documentation
Category: UWHC Administrative Policy
Policy Number: 8.20
Effective Date: January 1, 2017
Version: Revision
Section: Patient Care (Hospital Administrative)


To alert caregivers of potential and actual adverse drug events (allergic reactions, adverse drug reactions, and
medication events that result in patient harm) and to maximize safe and effective care.


A. Adverse Drug Reaction: An adverse drug reaction (ADR) is any response to a drug that is noxious,
unintended or undesirable and excessive which occurs at doses normally used in humans for prophylaxis,
diagnosis, therapy of disease or modification of physiological function. A significant ADR that requires
reporting includes one or more of the following criteria:
1. Identified patient morbidity that significantly complicates diagnosis or negatively affects
2. Requires discontinuing the drug (therapeutic or diagnostic) or modifying the dose.
3. Requires changing the drug therapy.
4. Requires additional treatment.
5. Necessitates admission to a hospital or prolongs stay in a health care facility.
6. Causes temporary or permanent patient disability, harm or death.
7. Any ADR not listed in the drug package labeling.
8. Any ADR reported with an investigational drug.
9. ADRs to drugs recently approved by the FDA.
Note: Drug withdrawal, drug abuse syndromes, accidental poisoning, and drug overdose
complications should not be defined as an ADR.
B. Drug Administration Error: Any preventable event that may cause or lead to patient harm or inappropriate
medication use while the medication is in the hands of a health care professional, patient or
customer. 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.
C. Drug Incompatibilities: drugs that chemically or physiologically interfere with one another and therefore
should not be mixed, administered together, or even given within a timeframe when they will interfere
with each other.
D. Allergy is defined as any abnormal or altered reaction to an antigen or allergen usually involving
hypersensitivity of immune cells to a specific substance (antigen or allergen) which results in an unwanted
reaction, e.g., hives, shortness of breath, difficulty in swallowing, nausea, vomiting, and anaphylactic
shock. It can also include skin rashes. These reactions occur in a minority of patients receiving the drug
and occur at usual or even small doses, particularly after the patient is sensitized.
E. Definition of a Medication Event: Hospital Administrative policy #4.22-Event Reporting, declares that a
medication event is any preventable, unintended event that may cause or lead to inappropriate medication
use and/or patient harm. This may include the failure of a planned action to be completed as intended
(error in execution) or the use of an inappropriate plan to achieve an aim (error in planning). Such events
may occur in any aspect of the medication use process. This definition includes those events that result in
patient harm, as well as circumstances or incidents that have the potential to cause patient harm
(examples of medication events include, but are not limited to, prescribing errors, order illegibility,
administration errors, and dispensing errors).
F. Immediately (i.e. reporting requirement):
1. Without delay, clinically earliest possible moment.
2. Time frame for reporting ADR to appropriate individuals (i.e. attending physician, director of

a. If a Harm Score of 6: within 60 minutes of observing ADR
b. If a Harm Score > 6: within 10 minutes of observing ADR
G. Harm Scores: (Prognosis from time of assessment)
1. -1: Unsafe conditions
2. -2: Near miss: fail safe design or safeguard worked effectively; person who made error noticed
and recovered from error; spontaneous action by practitioner/staff/patient/family prevented
event from reaching patient
3. -3: No harm evident, physical or otherwise: event reached patient but no harm was evident.
4. -4: Emotional distress or inconvenience: mild/transient anxiety/discomfort without need for
additional treatment except monitoring (i.e., observation, physical exam, lab/phlebotomy,
5. -5: Additional treatment required: intervention required during encounter or increased length of
stay, or expected treatment in future as a direct result of event, but no other injury.
6. -6: Temporary harm: bodily or psychological injury, but likely not permanent.
7. -7: Permanent harm: lifelong bodily or psychological injury or increased susceptibility to disease.
8. -8: Severe Permanent harm: lifelong bodily or psychological injury or disfigurement that
interferes significantly with functional ability or quality of life.
9. -9: Death: dead at time of assessment
A. Drug administration errors, adverse drug reactions, and drug incompatibilities that result in harm to the
patient must be immediately (see timeframe in II. F. 2.) reported to the attending physician via pager, or
direct communication (i.e. in person or via telephone) and, if appropriate, to the hospital-wide quality
assurance program.
1. If attending physician is unavailable, report immediately to covering physician.
2. Report ADE to attending physician as soon as he/she becomes available.
B. All medication errors that result in harm to the patient and suspected ADRs must be promptly documented
in patient’s medical record including those not subject to immediate reporting.
C. The nurse, physician and pharmacist are responsible for determining if the patient has a known
hypersensitivity or serious drug-related problem to certain substances during the initial inpatient
admission, emergency room or clinic interview, procedure area admission, and medical record review. The
screening must occur with each patient visit to a UWHC provider.
D. If unable to determine known hypersensitivity or drug-related problems from the patient, the provider
should check for the presence of a Medic Alert bracelet or necklace, Medilog identification bracelet or
similar "condition alert" card. In addition, the patient, family member or significant other should be asked
for known hypersensitivity or drug-related problems.
E. All patient care providers are responsible for documenting the information in the patient's medical record.
F. Upon inpatient admission and/or learning of hypersensitivity or drug-related problems the pharmacist will
be responsible for updating the patient's electronic health record.
G. The physician bears the final responsibility to confirm the allergic reaction and/or ADR, make the
diagnosis, and document in the electronic medical record.
H. The following proactive measures of ADR and drug incompatibility identifications are required to prevent
the majority of medication errors:
1. Observation of medication passes
2. Concurrent and retrospective patient clinical record reviews
3. Medication use evaluations of high alert medications
4. An ADR surveillance team
5. A drug regimen review for a potential ADE that automatically generates when certain indicator
drugs are ordered.

Medication events are reported using the University Health System Consortium (UHC) Patient Safety Net (PSN)
system (refer to Hospital Administration policy #4.22-Event Reporting). In the event a medication error (deemed
preventable upon review) is initially reported as an ADR, the matter will be reclassified as a medication event and
referred to the appropriate personnel for resolution per Hospital Administrative poic #4.22-Event Reporting.
A. All patient care providers are required to document allergic drug reactions and adverse drug reactions in
the patient's medical record.
B. Adverse drug reactions are reported using the University Health System Consortium (UHC) Patient Safety
Net (PSN) system (refer to Hospital Administration policy #4.22-Event Reporting).

C. Upon review of each ADR report submitted via PSN, a pharmacist in the Center for Drug Policy will check
the ADR/allergy listing in WISCR and modify it, if necessary, to reflect the newly reported ADR or allergy.
A report is prepared for the Pharmacy Medication Use Evaluation Committee, the Pharmacy and
Therapeutics Committee and the Food and Drug Administration where applicable. (See Pharmacy
Department Policy and Procedure #13.08 for details.)
D. At discharge from an admission or during an outpatient visit the health professional should identify the
need or desire of the patient for a bracelet/necklace to identify their condition. The following procedure
should be followed:
1. Medic Alert order forms may be obtained in the UW Health Pharmacy Department. A physician's
order is not required.

UWHC Administrative Policy #4.22 - Event Reporting
UWHC Pharmacy Department Policy #13.08 - Adverse Drug Reaction Evaluation and Reporting System


Sr. Management Sponsor: VP, Professional Services
Author: UWHC Medication Safety Committee Chair

Approval Committee(s): UWHC Medication Safety Committee; Pharmacy and Therapeutics Committee; Medical
Records Committee; UW Health Clinical Policy Committee


Peter Newcomer, MD
UW Health Chief Clinical Officer

J. Scott McMurray, MD
Chair, UW Health Clinical Policy Committee