Ministry of Health King Saud Medical Complex Total Quality Management Riyadh, Kingdom of Saudi Arabia ADMINISTRATIVE POLICY

AND PROCEDURE(APP) DEPARTMENT: King Saud Medical Complex (KSMC)/Drug and Poisoning Information center POLICY TITLE/DESCRIPTION: POLICY NUMBER AND VERSION: ADVERSE DRUG REACTION APP-KSMC-143-(V1) EFFECTIVE DATE: 15 January 2010 REPLACES NUMBER AND VERSION: REVISION DUE: 15 January 2012 NUMBER OF PAGES: 4 APPLIES TO: All Departments and Employees of King Saud Medical Complex

1. STATEMENT OF PURPOSE: 1.1 To establish a mechanism to ensure that adverse drug reaction are systematically reported and reviewed. 1.2 To convince health professionals that reporting of adverse drug reaction is their moral and professional obligation. 1.3 To reduce mortality and morbidity by early detection of drug safety problems in Patients and improving selection and rational use of drugs by health professionals 2. DEFINITION(s): 2.1 Adverse Drug Reaction by (World Health Organization (WHO)): World health organization defines adverse drug reaction is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or the modification of physiological function. 2.2 American Society of Hospital Pharmacy. ASHP defines a significant adverse drug reaction as any unexpected, unexpected, unintended, undesired or excessive response to a drug that: 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5 2.2.6 2.2.7 2.2.8 2.2.9 Require discontinuing the drug (therapeutic or diagnostic) Requires changing the drug therapy. Requires modifying the dose (expect for minor dosage adjustments). Necessitates admission to hospital. Prolongs stay in a health care facility. Necessitates supportive treatment. Significantly complicates diagnosis. Negatively affects prognosis. Or result in temporary or permanent harm, disability, or death.

2.3 Food and Drug Administration (FDA): Adverse drug reaction is serious Adverse event (event relating to drugs or device ) as in which the patient outcome is death ,life threatening (real risk of dying ) , hospitalization (initial or prolonged ) , disability Version (2) 15/01/2010 Page 1 of 11

Ministry of Health King Saud Medical Complex Total Quality Management Riyadh, Kingdom of Saudi Arabia ADMINISTRATIVE POLICY AND PROCEDURE(APP) DEPARTMENT: King Saud Medical Complex (KSMC)/Drug and Poisoning Information center POLICY TITLE/DESCRIPTION: POLICY NUMBER AND VERSION: ADVERSE DRUG REACTION APP-KSMC-143-(V1) EFFECTIVE DATE: 15 January 2010 REPLACES NUMBER AND VERSION: REVISION DUE: 15 January 2012 NUMBER OF PAGES: 4 APPLIES TO: All Departments and Employees of King Saud Medical Complex

, (signification , persistent , or permanent ), congenital anomaly ,or required intervention to prevent permanent impairment or damage. 3. EQUIPMENT/MATERIAL/FORM(s): Adverse drug reaction reports and information 4. POLICY STATEMENT: It is the policy of the drug and poisoning information center to establish mechanism to ensure that adverse drug reaction are systematically reported and reviewed. 5. PROCEDURE: 5.1 REPORTING 5.1.1 Any staff who witnesses suspected adverse drug reaction will notify charged nurse 5.1.2 5.1.3 5.1.4 The charge nurse will immediately contact the attending physician and nursing supervisor to report the possibility of an adverse drug reaction The charge nurse will complete the nursing section of the adverse drug reaction Report The physician will examine the individual, order necessary intervention if needed, and will complete the medical section of the adverse drug reaction report or call drug and poisoning information presentative to take care of it. The physician will notify and forward the report to drug and poisoning information center or drug and poisoning information center presentative.

5.1.5 5.1.6

5.2

The drug and poisoning information center will evaluate each report and, when appropriate, will make recommendation for future evaluation to submit significant adverse drug reaction report to the Saudi food and drug administration, and the manufacturer, prompting publication and presentation of important adverse drug reaction s to the medical community DOCUMENTATION Page 2 of 11

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Ministry of Health King Saud Medical Complex Total Quality Management Riyadh, Kingdom of Saudi Arabia ADMINISTRATIVE POLICY AND PROCEDURE(APP) DEPARTMENT: King Saud Medical Complex (KSMC)/Drug and Poisoning Information center POLICY TITLE/DESCRIPTION: POLICY NUMBER AND VERSION: ADVERSE DRUG REACTION APP-KSMC-143-(V1) EFFECTIVE DATE: 15 January 2010 REPLACES NUMBER AND VERSION: REVISION DUE: 15 January 2012 NUMBER OF PAGES: 4 APPLIES TO: All Departments and Employees of King Saud Medical Complex

5.2.1

The charge nurse will document in the patient s medical record, the events associated with reporting the suspected adverse drug reaction to include, but not limited to: a. Sign and symptoms which is promoted the adverse drug reaction reporting procedure b. Date and time the staff notified the suspected adverse drug reaction c. Suspected medication need induce adverse drug reaction. d. Suspected medication need induce adverse drug reaction.

5.3

The physician will document in the patient medical record, the adverse drug reaction along with the interventions, if any are necessary 5.4 The drug and poisoning information center will maintain all adverse drug reaction reports and communicate pertinent data related to, to these reports to the total quality management, Ministry of health, Saudi Food &Drug Administration (SFDA), Saudi Food and Drug Authority (SFAD), European Medicines Agency (EMEA).

6. RESPONSIBILITY: It is the responsibility of the Drug &Poisoning Information Center to review &modify this policy & procedure 7. REFERENCES CBAHI resource manual

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Ministry of Health King Saud Medical Complex Total Quality Management Riyadh, Kingdom of Saudi Arabia ADMINISTRATIVE POLICY AND PROCEDURE(APP) DEPARTMENT: King Saud Medical Complex (KSMC)/Drug and Poisoning Information center POLICY TITLE/DESCRIPTION: POLICY NUMBER AND VERSION: ADVERSE DRUG REACTION APP-KSMC-143-(V1) EFFECTIVE DATE: 15 January 2010 REPLACES NUMBER AND VERSION: REVISION DUE: 15 January 2012 NUMBER OF PAGES: 4 APPLIES TO: All Departments and Employees of King Saud Medical Complex

8. APPROVALS: Name Prepared By Sis.Julica U. Kurais Dr. Yousef Ahamad Alomi Dr. Naeema Taha Al Shlaan Reviewed By Dr. Saif Ibrahim Title
DPI Nurse Coordinator

Signature

Date 2/1/2010 2/1/2010 2/1/2010 3/1/2010 3/1/2010

Head, Drug & Poisoning Information Center

Inpatient Pharmacy Supervisor

TQM Director

Sis. Muneera Al Hawsawi Approved By Dr.Nasser Al Dosary Dr. Nabil AlGosaibi Dr. Adnan Al Abdulkareem

Director of Nursing

Chairman of P&T committee

5/1/2010 5/1/2010 5/1/2010

Asst. Chief Executive Officer for Medical Affairs

Chief Executive Officer

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Ministry of Health King Saud Medical Complex Total Quality Management Riyadh, Kingdom of Saudi Arabia ADMINISTRATIVE POLICY AND PROCEDURE(APP) DEPARTMENT: King Saud Medical Complex (KSMC)/Drug and Poisoning Information center POLICY TITLE/DESCRIPTION: POLICY NUMBER AND VERSION: ADVERSE DRUG REACTION APP-KSMC-143-(V1) EFFECTIVE DATE: 15 January 2010 REPLACES NUMBER AND VERSION: REVISION DUE: 15 January 2012 NUMBER OF PAGES: 4 APPLIES TO: All Departments and Employees of King Saud Medical Complex

9. POLICY AND PROCEDURE (PP) HISTORY: Initial PP: Version 1 ___APP-KSMC-143 (V1) Dated: _ January 15, 2010 Replaced by: Version_______________________ Dated: ________________ Deleted Date: ______________________________ Replaced by New PP: PP No. &Version_____________________Dated__________________

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