Role of the Pharmacist in Adverse Drug Reaction Monitoring and Reporting

Pharmacists should exert leadership in the development, maintenance, and ongoing evaluation of ADR programs. They should obtain formal endorsement or approval of such programs through appropriate committees (e.g., a pharmacy and therapeutics committee and the executive committee of the medical staff) and the organization’s administration. In settings where applicable, input into the design of the pro-gram should be obtained from the medical staff, nursing staff, quality improvement staff, medical records department, and risk managers.

The pharmacist should facilitate

1. Analysis of each reported ADR,

2. Identification of drugs and patients at high risk for being involved in ADRs,

3. The development of policies and procedures for the ADR-monitoring and reporting program,

4. A description of the responsibilities and interactions of pharmacists, physicians, nurses, risk managers, and other health professionals in the ADR program,

5. Use of the ADR program for educational purposes,

6. Development, maintenance, and evaluation of ADR records within the organization,

7. The organizational dissemination and use of information obtained through the ADR program,

8. Reporting of serious ADRs to the FDA or the manufacturer (or both), and

9. Publication and presentation of important ADRs to the medical community.

Direct patient care roles for pharmacists should includes

patient counseling on ADRs,

identification and documentation in the patient’s medical record of high-risk patients,

monitoring to ensure that serum drug concentrations remain within acceptable therapeutic ranges,

and adjusting doses in appropriate patients (e.g., patients with impaired renal or hepatic function).

Courtesy: Medication Misadventures–Guidelines