/policies/,/policies/clinical/,/policies/clinical/uwhc-clinical/,/policies/clinical/uwhc-clinical/department-specific/,/policies/clinical/uwhc-clinical/department-specific/pharmacy/,/policies/clinical/uwhc-clinical/department-specific/pharmacy/drug-policy/,

/policies/clinical/uwhc-clinical/department-specific/pharmacy/drug-policy/138.policy

20150116

page

100

UWHC,

Policies,Clinical,UWHC Clinical,Department Specific,Pharmacy,Drug Policy

Adverse Drug Reaction Evaluation and Reporting System (13.8)

Adverse Drug Reaction Evaluation and Reporting System (13.8) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Drug Policy

13.8

POLICY & PROCEDURE





Effective Date:

January 2002
⌧Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13.8

Original
⌧Revision 4/12
Page 1
of 6
Title: Adverse Drug Reaction Evaluation
and Reporting System


I. PURPOSE: To have a system for the review and reporting of adverse drug reactions
(ADRs). The Pharmacy Department supports the University of Wisconsin Hospital and
Clinics (UWHC) Administrative Policy #8.20 Adverse Drug Event Documentation through
the steps outlined below.

II. POLICY: Adverse drug reactions (ADRs) reported for patients treated at the UWHC will
be reviewed by the Drug Policy Program (DPP). The DPP will coordinate internal monthly
reporting, reconciling Medical Record ICD-9-CM reporting and reviewing, and submitting
selected reports to the Food and Drug Administration (FDA) pursuant to the FDA
guidelines. When appropriate, identified ADRs will be reviewed and evaluated in more
depth by DPP staff, to provide a means of preventing or minimizing further ADRs through
the implementation of appropriate action or intervention. Those ADR reports deemed
preventable will be referred to the Medication Safety Committee for further review and
action and will be reported via the UWHC occurrence reporting system. The Medication
Use Evaluation (MUE) Committee and the Pharmacy and Therapeutics (P&T) Committee
will review the reported ADRs monthly, quarterly, and yearly. Monthly ADR reports will
be forwarded to the UWHC Authority Board.

Filing of an ADR report is not meant to prove cause and effect, but only to document a
temporal association which can then be evaluated by the medical team.

III. PROCEDURE:

A. Guidelines for reporting ADRs
1. Adverse drug reactions should be reported and documented in the patient’s record as
described in UWHC Administrative Policy #8.20. If unsure whether an ADR or
drug allergy is reportable, a report should be submitted through the UHC Patient
Safety Net (PSN) system and/or discussed with the Manager of the DPP or staff
pharmacist in the DPP.
2. The PSN system is accessible on the Novell Application Window on all UWHC
workstations.
B. Responsibilities:
1. The health care professional upon discovering a clinical manifestation that may be
associated with a drug, discusses the reaction with the patient care team. If the
clinical manifestation is suspected of being drug-induced, an assessment of whether
the ADR is reportable is made.


POLICY & PROCEDURE





Effective Date:

January 2002
⌧Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13.8

Original
⌧Revision 4/12
Page 2
of 6
Title: Adverse Drug Reaction Evaluation
and Reporting System


a. This policy and procedure does not preclude other interested healthcare
professionals from submitting an ADR report through the PSN system.
b. If a pharmacist is available in the practice area (for example: inpatients units or
a clinic staffed with a pharmacist), the pharmacist will:
i. Review the patient's chart to assure that the ADR has been
documented in the medical record, and if not, discuss the ADR with
the attending physician to assure that the documentation is
completed.
ii. Provide any necessary recommendations regarding management of
the ADR.
iii. If the occurrence resulted in an actual or potential sentinel event
which may require assessment by Risk Management, notify the
Director of Pharmacy immediately. The Director of Pharmacy will
notify Risk Management, if appropriate.
iv. Submit a completed PSN event report with the name of the attending
physician who was attending on the day of the occurrence or the date
of the report whichever is most appropriate and any other attending
physician involved (e.g. the consultant attending physician or the
attending physician responsible for a procedure). Note: If the drug is
investigational, the name of the principal investigator must also be
recorded.
v. The report is immediately forwarded electronically to the DPP, the
Director or Pharmacy and staff in Risk Management.
vi. Document in the PSN report, the date and time of communication
with the physician regarding the ADR and any intervention
discussed. In addition, document others informed of the ADR
including the patient or family.
vii. Document the reaction as outlined in Administrative Policy and
Procedure #8.20.
c. For clinics or other areas of the hospital not having pharmacist coverage:
i. Any patient care provider will submit a PSN event report to be
forwarded as in b.iv above and document the reaction as per
Administrative Policy and Procedure #8.20.
ii. DPP staff will:
ƒ Complete the PSN report as described in 2.2 below.

POLICY & PROCEDURE





Effective Date:

January 2002
⌧Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13.8

Original
⌧Revision 4/12
Page 3
of 6
Title: Adverse Drug Reaction Evaluation
and Reporting System


ƒ If the occurrence resulted in an actual or potential
sentinel event, notify the Director of Pharmacy
immediately.
d. The patient care team should inform the patient and/or family of a suspected
ADR and discuss the advisability of a bracelet, necklace or some other form
of identification to indicate the ADR or allergic drug reaction.
2. The Manager of the DPP or designee will coordinate the following:
a. Review the reports for completeness and accuracy.
i. Audit at least 20% per month for documentation of the ADR in the
medical record.
b. Immediately notify the Director of Pharmacy if the occurrence resulted in an
actual or potential sentinel event if not done previously.
c. Review the literature where necessary and provide the decentral pharmacist
or clinic pharmacist with additional information and any recommendations
for intervention.
d. Complete the ADR report in the PSN system, which includes the calculation
and entry of the probability of the clinical manifestation being an ADR using
Naranjo’s probability scale (see Appendix A).
e. Forward copies of the ADR report to the attending physician of record for
that hospital admission and to any other physician deemed appropriate on
review of the ADR. If the implicated drug is investigational, a copy should
be sent to the principal investigator for the study and to the Pharmaceutical
Research Center Coordinator. .
f. Complete follow-up review of ADRs which are unusually severe, occur due
to drug interaction or unknown mechanism, a repeat occurrence or an
apparent contraindication, as in a patient with a documented penicillin
allergy being given dicloxacillin.
i. An in-depth review and follow-up report will focus on the following
required information as well as other pertinent information and the
written documentation will be attached to the original PSN ADR
report:
ƒ Key information not documented in the PSN report
ƒ Assessment of preventability
ƒ Action plan if applicable with recommended
interventions and any further review necessary
ƒ Documentation that any needed interventions were
completed

POLICY & PROCEDURE





Effective Date:

January 2002
⌧Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13.8

Original
⌧Revision 4/12
Page 4
of 6
Title: Adverse Drug Reaction Evaluation
and Reporting System


ƒ Name of pharmacist completing the in-depth review
ƒ Date of in-depth review
ii. The ADR follow-up report will summarize the review and assess
preventability. A copy of the follow-up report should accompany the
ADR report copy sent to the attending physician and the reporting
pharmacist.
ADRs deemed preventable will subsequently be reported via the
UWHC occurrence reporting system.
g. Send monthly ADR summary reports and any follow-up reports to the MUE
Committee and then to the P&T Committee.
h. Submit feedback information to all pharmacy personnel with inclusion of
information in the pharmacy department's weekly newsletter, at a pharmacist
staff meeting, and/or presentation of cases-in-point at pharmacy inservices.
i. Submit feedback information to the physicians and nurses may occur
through their respective newsletters, or inservices.
j. Submit PSN reports meeting the following criteria to the FDA after personal
identifiers are removed:
i. Any ADR which is not listed in the official package labeling for the
drug.
ii. Serious reactions which result in death, permanent injury or
disability, initial or prolonged hospital stay, congenital anomaly, life-
threatening morbidity or reactions which require intervention to
prevent permanent impairment/damage.
iii. Any reaction reported for an investigational drug.
iv. The FDA prefers a focus on drugs or biologicals marketed in the last
three years. NOTE: The manufacturer is notified via the FDA.
k. Keep original PSN ADR reports on file in the DPP for 5 years and archived
electronically for an additional 5 years.
l. Reconcile monthly ADR reports with those identified through ICD-9-CM
coding by Medical Records to:
i. Determine if medical records are capturing pharmacy reported
ADRs.
ii. Determine if ADRs identified by Medical Records have been missed
in the pharmacy reporting system.
ƒ Review medical records for serious ADRs identified by
Medical Records but not reported via the PSN system.

POLICY & PROCEDURE





Effective Date:

January 2002
⌧Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13.8

Original
⌧Revision 4/12
Page 5
of 6
Title: Adverse Drug Reaction Evaluation
and Reporting System


ƒ Submit a PSN report if necessary after discussion with the
attending physician.
iii. Generate a quarterly report documenting reconciliation of the reports
submitted in PSN and ADRs reported by Medical Records.
m. Provide routine ADR reporting reminders for health care professionals to
encourage reporting of significant ADRs.
n. Forward ADR reports with any follow-up review or pertinent MUE
Committee or P&T Committee minutes to the appropriate Quality Assurance
Committee on a case-by case basis.
o. Provide yearly ADR summary report to MUE Committee, to P&T
Committee, and to Medication Safety Committee.

3.0 MUE Committee Responsibilities
a. Review monthly ADR reports
i. Approve or recommend reports to be sent to the FDA.
ii. Review the in-depth reviews submitted by the DPP and
ƒ Request further information if needed.
ƒ Suggest interventions to prevent recurrence.
iii. Request in-depth review of ADR reports
iv. Refer any problems noted to other department/divisions when
appropriate (e.g. sterile products area, quality assurance committees)
v. Forward the monthly report, reviews and recommendations to the P&T
Committee.
b. Review quarterly and yearly ADR summary reports
for trends not noted in the monthly report.
Request further information when appropriate
Recommend intervents when appropriate
Forward to the P&T Committee for final review and any necessary action
i. P&T Committee Responsibilities
ii. Review monthly reports approving those reports to be sent to the FDA
and review in-depth reports
iii. Review and evaluate quarterly and yearly reports to identify trends that
may respond to corrective action or education.
iv. Recommend necessary further action to decrease the incidence of ADRs.
v. After P&T Committee review, reports may be sent to the Quality
Assurance Department for forwarding to any appropriate medical or
surgical departments.

POLICY & PROCEDURE





Effective Date:

January 2002
⌧Pharmacy Policy Manual
Chapter: Drug Policy
Operations Procedure Manual
Chapter:

Policy #: 13.8

Original
⌧Revision 4/12
Page 6
of 6
Title: Adverse Drug Reaction Evaluation
and Reporting System





Approved By: ____________________________
Director of Pharmacy Services

Date: ____________