Name of Policy:
Adverse drug reaction reporting
Policy Number:
3364-100-70-02
Department:
Hospital Administration
Approving Officer:
Chief Executive Officer
Responsible Agent:
Chief Medical Officer
Effective Date: 10/1/2023
Initial Effective Date: March 8, 2000
Scope:
The University of Toledo Medical Center and its
Medical Staff
New policy proposal
Minor/technical revision of existing policy
Major revision of existing policy
X
Reaffirmation of existing policy
(
A) Policy Statement
A
ll adverse drug reactions (“ADR”) shall be reported in Patient Safety Net (PSN) or directly to pharmacy. An ADR is
defined as any unexpected unintended, undesired, or excessive response to a that:
1. requires discontinuation of the drug
2. requires changing drug therapy
3. requires modifying the dose (except for minor dosage adjustments
4. necessitates admission to a hospital
5. prolongs stay in a health care facility
6. necessitates supportive treatment
7. negatively affects prognosis
8. results in temporary or permanent harm, disability or death. Uncommon reactions are those which occur in less than
5%
of patients taking the drug. Unexpected reactions are those which have not been well described in the medica
l
l
iterature, and which are not obviously extensions of the therapeutic actions of the drug.
Definitions:
For reporting purposes: FDA categorizes a serious adverse event as one in which “the patient outcome is death, life-
threatening, hospitalization, disability, congenital anomaly, or required intervention to prevent permanent impairment or
damage
Non-ADR
1. Side effect: well-known reaction resulting in little or no change in patient management (e.g. drowsiness for opioids
or nausea from chemotherapy). Side effects are predictable in frequency and an effect whose intensity and
occurrence are related to the size and dose.
2. Drug withdrawal, drug-abuse syndromes, accidental poisonings, and drug-over-dose complications are not ADRs
(
B) Purpose of Policy
To monitor adverse drug reactions at the University of Toledo Medical Center. The data collected will aid the Pharmacy
and Therapeutics Committee in its assessment of drug use, individual patient incidents related to drug use, and drug
interactions, and will provide the basis for medical and nursing staff education that may minimize the occurrence of adverse
reactions.
(C) P
rocedu
re
A
ppropriate documentation of the adverse reaction and treatment received must be made in the Medical Record. In
addition, the reaction will be reported to the Pharmacy according to the following procedure:
A. M
onitoring
a. Ongoing and concurrent by pharmacists, nurses, physicians, and patients
b. Prospective for high risk drugs and patients
c. Monitoring alerting orders such as reversal agents
d. Prescribers, caregivers, and patients should be notified
B.
R
eporting Mechanism
Policy 3364-100-70-02
Adverse Drug Reaction Reporting
Page 2
1. Any member of the medical, nursing, pharmacy, or utilization review staff may initiate the report. The report
should be initiated within 24 hours after the reaction is recognized. The report may be entered into Patient Safety
Net or called into the "ADR Hotline", Ext. 8359. Suspected ADRs will also be identified through the AcuDose
medication dispensing system.
2. The information on the report form will include:
♦ Date of Report
♦ Date of Reaction
♦ Patient Location/Nursing Unit
♦ Patient Name
♦ Diagnosis (if known)
♦ Known allergies/hypersensitivities
♦ Drug suspected of causing reaction
♦ Dose given and date/time dose given
♦ Other concurrent drugs used within 24 hours (i.e., prescription, OTC, herbal, etc.)
♦ Description of reaction
♦ Treatment of reaction and response
♦ Reporter name (optional)
C Pharmacy Review and Data Collection
1. The pharmacy will rate the ADR using predefined criteria as to probability, severity, and type of ADR.
2. Records will be kept of the number of reactions to each drug.
3. The pharmacy will provide the physician or nurse with any information that might prevent the recurrence of the
adverse reaction, or which might allow treatment to shorten the duration of the reaction.
4. The pharmacy will assign a probability score in Patient Safety Net utilizing subjective questions and tools
D. Review by Pharmacy and Therapeutics Committee.
The Pharmacy and Therapeutics Committee will review adverse drug reactions that have been reported to the
Pharmacy. One or more of the following actions may be taken:
1. The information may be provided to the manufacturer if the adverse reaction is not well known, or if the drug was
only recently released for use
2. Medical or Nursing Staff may be informed of the reaction as a part of the educational function of the Pharmacy, and
of the Pharmacy and Therapeutics Committee. Related information (recommended treatment of the reaction, ways
to avoid the reaction, etc.) will also be provided. This will be done by memo, the Drug Information bulletin,
Medical Staff Bulletin, or other means.
3. Depending on the nature of the reaction and its frequency, a drug utilization review may be initiated, and the
committee may re-evaluate the inclusion of the drug in the Hospital Formulary.
4. Depending on the severity and type of reaction, a report should be filed with the FDA through the standard
reporting mechanism.
5. Any other actions that may reduce the risk of recurrence of the adverse reaction, or serve to educate the nursing and
medical staff.
Policy 3364-100-70-02
Adverse Drug Reaction Reporting
Page 3
Review/Revision Date:
09/29/2023
7/30/84
4/15/86
6/26/87
12/14/88
2/17/89
5/9/90
9/11/91
4/14/93
9/11/96
9/14/98
9/12/01
9/8/04
9/12/07
11/15/2010
11/01/2013
11/01/2016
11/18/2019
11/15/2022
8/1/2023
Date
10/03/2023
Chief Executive Officer
Date
HAS
Chairman, Pharmacy & Therapeutics Committee
Director, Pharmacy
Next Review Date: 8/1/2026
Policies Superseded by This Policy: 7-70-02
References: ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting