Relationship Between the Clinical Pharmacist & Antibiotic Use by Using the Electronic Program

Relationship Between the Clinical Pharmacist & Antibiotic Use in Selected Infectious Disease Hospitals in El Beheira by Using the Electronic Program, Retrospective Cohort

A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Pharmacists; Electronic Medical Record
• Intervention / Treatment: Other: NO intervention

Detailed Description

The role of clinical pharmacist includes :

1. a check of suitable selection and dosing of antimicrobials according to the diagnosis, type of infection, antimicrobial cultures as possible, comorbidities of patients (renal or hepatic function, etc), adverse effect, and drug interaction with other drugs.
2. Documentation of the clinical intervention, cost-saving, adverse effect,, antimicrobial culture and antimicrobial consumption on the electronic program (CPC "clinical patient care").
3. The clinical pharmacist inspector reviews the data recorded on CPC.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Maged El-Setouhy; Email: ma.elsetouhy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who administered antimicrobials

Description

Inclusion Criteria:

• All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites).

Exclusion Criteria:

• Any other cause of hospital admission other than infectious disease.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exposure group; Data from electronic clinical pharmacist records of two infectious disease hospitals	Other: NO intervention; There is no intervention
Non-exposure group A; Data from medical records of the hospital with no clinical pharmacy.	Other: NO intervention; There is no intervention
Non-exposure group B; Data from a medical record of the hospital with clinical pharmacy, but the department did not cover by the clinical pharmacy	Other: NO intervention; There is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial consumption	consumption of antimicrobials (defined daily doses / 100 patient-days)	2 years
Days of therapy (DOT)	Number of days of each antimicrobial received for therapy	2 years
Length of therapy(LOT)	The number of days a patient takes an antibacterial drug, regardless of the number of different medications	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cost savings	(initial treatment cost × days before intervention) - (cost after intervention × days with this treatment),	2 years
Mortality rate	in-hospital mortality rate (%)	2 years
Antimicrobial resistance	resistance defined as resistance to at least one antimicrobial from the panel for all organisms, and for a subset of organisms belonging to the ESKAPE group (Enterococcus faecium, S. aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa , and Enterobacter spp.	2 years
The incidence of adverse reaction of antimicrobial	An unexpected medical problem that happens during treatment with antimicrobial.	2 years

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: Ministry of Health and Population, Egypt
• Investigators: Principal Investigator: Amira zidane, Ministry of Health and Population, Egypt

Publications and helpful links

General Publications

• Karakonstantis S, Kalemaki D. Antimicrobial overuse and misuse in the community in Greece and link to antimicrobial resistance using methicillin-resistant S. aureus as an example. J Infect Public Health. 2019 Jul-Aug;12(4):460-464. doi: 10.1016/j.jiph.2019.03.017. Epub 2019 Apr 10.
• Dyar OJ, Huttner B, Schouten J, Pulcini C; ESGAP (ESCMID Study Group for Antimicrobial stewardshiP). What is antimicrobial stewardship? Clin Microbiol Infect. 2017 Nov;23(11):793-798. doi: 10.1016/j.cmi.2017.08.026. Epub 2017 Sep 4.
• Ourghanlian C, Lapidus N, Antignac M, Fernandez C, Dumartin C, Hindlet P. Pharmacists' role in antimicrobial stewardship and relationship with antibiotic consumption in hospitals: An observational multicentre study. J Glob Antimicrob Resist. 2020 Mar;20:131-134. doi: 10.1016/j.jgar.2019.07.009. Epub 2019 Jul 16.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: August 7, 2021
• First Submitted That Met QC Criteria: August 7, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: clinical pharmacist; antibiotic use; antibiotic consumption; cost-saving
• Other Study ID Numbers: 14-2021/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No