Community Mental Health &
Substance Abuse Services
of St. Joseph County
Operating
Procedure
Subject:
Psychiatric Services
Adverse Reaction to Medications
Application:
All Departments
Effective
3/21/96
Reviewed
6/1/98
11/30/04
44.14
Revised
6/1/97
4/1/01
6/5/06
1/12/08
05/07/11
12/17/13
Approved
Policy
CMHSAS-SJC shall provide pharmacologic services to address the psychiatric need of customers
and assure medications are administered according to current practice standards and applicable
statute.
Purpose
To ensure customer well being and provide for reporting adverse reaction to medications.
Definitions:
Adverse Drug Reaction: Defined as any of the following which occurs as a result of administration of
a medication, both prescription and non-prescription.
1.
Death.
2.
Illness or reaction which requires medical intervention, hospitalization, or emergency
care.
3.
Severe allergic reaction which results in discontinuation of a drug because of rash,
swelling and/or respiratory involvement.
4.
Rare or unusual reaction which may be attributed to drugs.
5.
Permanent or temporary disability.
6.
Reactions experienced by multiple customers given the same specific product.
7.
Severe extra pyramidal symptoms: difficulty swallowing, akathisia (motor
restlessness) and/or muscle spasm.
Procedure
1.
Any staff member who observes a customer experiencing a possible adverse reaction to
medication shall immediately notify the prescribing physician or nurse/medical assistant.
Page 1 of 5
Operating Procedure
Subject:
44.14
Psychiatric
Services/
Adverse Reaction to Medications
2.
The Medical Director or designee shall report adverse drug reactions in the Medical Staff
meetings.
3.
All severe reactions that match any of the definitions in this procedure shall be reported to
the FDA and the drug manufacturer.
4.
1.
The physician or his/her designee shall complete FDA form #1639, “Adverse
Reaction Report” (see attachment).
2.
The original form shall be sent to the FDA and a copy shall be retained and attached
to the Incident Report which documents the reaction.
Severe extra pyramidal symptoms shall be evaluated by CMHSAS-SJC Physician/nurse,
using an electronic AIMS (Abnormal Involuntary Movement Scale) checklist every quarter.
The Physician must do one of the AIMS assessments per year. The nurse may do the other
three.
1.
Results shall be documented in Physician’s Progress Notes.
Review Responsibility
This policy/procedure will be reviewed annually by the Medical Committee.
Attachments
1.
Incident Report form.
2.
FDA for #3500 “Adverse Reaction Report.”
3.
AIMS Checklist.
Page 2 of 5
106745342
COMMUNITY MENTAL HEALTH OF ST. JOSEPH COUNTY
Incident/Accident/Illness Report
TYPE OF INCIDENT:
Recipient
Property
Employee (CMH only)
NAME OF RECIPIENT/EMPLOYEE:
Other
CASE #:
Date incident occurred/noticed:
Time incident occurred/noticed:
Site/location incident occurred/noticed:
Name/Title of reporting person:
Date/Time:
List any witnesses:
Description of incident & action taken: (include cause and extent of injuries) (continue on back of page if needed):
A Summary of this incident has been entered into the clinical record (e.g., case note, shift note, tracking log, etc.)
What will be done if the incident/accident/illness happens again?
Is a meeting needed?
No
Yes If so, with whom? Purpose.
Signature/Program Site Supervisor:
Date/Time:
NOTIFICATION:
Written
Provider
Supports Coordinator
Guardian/Parent
Recipient Rights
Adult Protective Services
Community Mental Health
Other
Name
Date/Time
Phone
DO NOT WRITE BELOW THIS LINE (TO BE COMPLETED BY RECIPIENT RIGHTS OFFICER)
Category:
Incidents & Accidents
Classification of incident:
1. Injury/Illness
Critical Incidents
2. Unusual Incident
5. Inappropriate Sexual Act
3. Behavioral Episode
6. Medication Error
Action taken/treatment ordered:
1. No follow-up
2. Support Plan or Treatment Modification
5. Environmental Modification
6. Improvement Team Chartered
8. External Consultation
Page 3 of 5
4. Abuse and Neglect
7. Criminal Offense
3. Training/Education
7. Root Cause Analysis
8. Death
4. Staff discipline