The Role of Clinical Pharmacist in Monitoring Drug Therapy in the Cardiovascular and Coronary Care Units in Libya. (BSU)

Assessment of role of clinical pharmacist in decreasing morbidity and mortality among coronary artery disease patients.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: clinical pharmacy application

Detailed Description

- Methodology: Follow-up patients from (A to Z) and their risk factors in all phases of disease (CAD) in groups with advised patients to lose weight, decrease smoking, and take medication on time.

Monitoring drugs to CAD by studying its Pharmacodynamic:

Mechanism of action, therapeutic uses [indication], adverse effect and suitable doses, and drug-drug interactions and contraindications

* The study shows the Compare between the patients in (Medical Center Hospital) with and without guidelines of clinical pharmacy. Were managed all by setting a plan with the cardiologist in Libya.

Follow-up was for the one hundred patients in the three groups {Outpatient, Inpatient, and the patients in Cardio Care Unit - CCU}.

• First subgroup, Outpatient: monitored the drugs used in HTN, DM, and Hyperlipidemia (dyslipidemia) to decrease levels of patients who come to the hospital with IHD; therefore, reduce morbidity. Also, it was followed by measurement of BP twice weekly, test for Blood sugar (glucose level) once monthly, and tests the Low-Density Lipoprotein (LDL) at the cardiologist's request.
• Second subgroup, Inpatient: monitored drugs according to international guidelines of clinical pharmacy to decrease the medication errors and management of the drug of stable angina and protected patients from increasing the problem, myocardial infarction, and reduce rates of entry to CCU.

• Third subgroup, Patients in CCU: Practiced the international roles of clinical pharmacy to monitor drug use to unstable Angina and MI, to decrease mortality in Libya.

  • Method of analysis:

Were monitored one hundred patients and divided into:

• Twenty patients from (outpatient) divided to (10pts.-10pts.). (Ten patients) was written the data collected in accordance with the system adopted at the (Medical Center Hospital).

(Ten patients)They are patients who applied the guidelines of clinical pharmacy to them in (Medical Center Hospital) by recommending cardiologists practice the clinical pharmacy guidelines and tailoring doses.

• 50 of inpatients as outpatient (25pts.-25pts.).

• 30 patients in CCU divided into (15pts.-15pts.).

  - The statistical analysis was the comparison between the two groups:

• The first group of patients was undergoing treatment in the (Medical Center Hospital) without applying guidelines. (10 patients-25pts.-15pts.).
• The second group; are a group of patients undergoing treatment in the (Medical Center Hospital) in accordance with guidelines. (10pts.-25pts.-15pts.).

The comparison was in terms of the rate of survival, the speed of symmetry to heal ( i,e. responsiveness to medications), the rate of complications, and death for both groups.

- The purpose of this review is to summarize the role of clinical pharmacy benefits in all aspects of cardiovascular diseases (CVD) in hospitalized patients.

Managed the risk factors (hypertension, diabetes, dyslipidemia) and Ischemic heart disease by monitoring the common drugs in Libya:

• Diuretics: ACEIs and ARBs for hypertension.
• Insulin and Biguanides (Metformin) for diabetes.
• Statins for dyslipidemia.
• Organic nitrates: CCB, BB, Antiplatelets, Anticoagulant, and Fibrinolytics for ischemic heart disease.

And the summary of the aim of the work is the practice of guidelines of clinical pharmacy to manage coronary artery disease to reduce levels of morbidity and mortality in Libya and to prove the need for the presence of clinical pharmacists in Libyan hospitals.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, +20
    • Beni-Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Follow-up one hundred patients, in two groups, divided each one into three subgroups {10-Outpatient, 25-Inpatient and 15 patients in Cardio Care Unit - CCU}.

• The first group of patients was undergoing treatment in the (Medical Center Hospital) without applying clinical pharmacy guidelines. (10 patients-25pts.-15pts.).
• The second group; are a group of patients undergoing treatment in the (Medical Center Hospital) in accordance with clinical pharmacy guidelines. (10pts.-25pts.-15pts.).

Description

Inclusion Criteria:

- The inclusion criteria were all adults ≥40 years of age, with a diagnosis of CAD.

Exclusion Criteria:

• exclusion criteria were patients with various comorbidities such as liver or kidney disease; patients intake alcohol, cardiac surgery and refusal to give informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I (control group); was collect data without any interference (without clinical pharmacy guidelines). Subgroup: 10 outpatient, 25 inpatient, 15 patient in CCU.
Group II (observation group); application of clinical pharmacy guidelines and management CAD. Subgroup: 10 outpatient, 25 inpatient, 15 patient in CCU.	Drug: clinical pharmacy application; assessment clinical pharmacist in management of CAD and ICU patients.; Other Names: Follow-up patients and their drugs, to improve health and reduce morbidity and mortality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina pectoris.	Periodically data collected. [ex: the measurements of blood pressure, glucose blood serum, and LDL - (and taken the average during the period)]. The parameters in the research (angina, response to treatment, complication rate, and mortality) - were quantitatively collected, as the results added to the paper contain the number of patients with details of their complications or the cause of death of patients who died). The measuring of FBG level (mg/dl), and (LDL-C) mg/dl - was then performed using a fully automated chemistry analysis instrument by Roche company (Cobas Integra 400 plus). And using specific kits for blood glucose levels (System ID 07-6831-6) and using kits for (LDL-C) (System ID 07-6726-3), Troponin (ng\ml) was performed by using (Beckman coulter - Access 2). Angina pectoris was more predominant in patients in group (I); vs. in group (II) with a statistically significant difference.	18 months, from Jan 2021 to June 2022.
Responsiveness to medications.	Periodically data collected. [ex: the measurements of blood pressure, diabetes, lipid profile, and weight - (and taken the average during the period)]. The parameters in the research (angina, response to treatment, complication rate, and mortality) - were quantitatively collected, as the results added to the paper contain the number of patients with details of their complications or the cause of death of patients who died). Follow-up patients, their clinical state and side effects of medications, Following the number of Hospitalization decreased. Responsiveness to medications was significantly higher among patients from the group (II); compared with a control group (I)	18 months, from Jan 2021 to June 2022.
The incidence of complications.	The complications are noticeable: myocardial infarctions [Troponin was perpetrated by using by (Beckman coulter)(Access 2) ng\ml], cardiac arrhythmias [by ECG], cardiogenic shock [after MI with HF and low BP], HTN crisis {BP measure, DKA [high blood glucose with (+) positive Ketones. Data were collected quantitatively, as the results added to the paper contain the number of patients with details of their complications).	18 months, from Jan 2021 to June 2022.
The mortality.	The causes of death are cardiogenic shock, ventricular tachycardia, and myocardial infarction.	18 months, from Jan 2021 to June 2022.

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Cairo University; Medical Center Hospital, libya
• Investigators: Principal Investigator: Asmaa S. alhomri, BCH.PH, Bachelor of Pharmaceutical Sciences, Faculty of Pharmacy, Omar Elmokhtar University, Tobruk, Libya.; Study Director: Raghda S. Hussien, Lecturer, Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.; Study Director: Eman K. Abdelall, Professor, Organic Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Beni- Suef, Egypt.; Study Director: Ahmed A. Battah, Professor, Critical Care Department, Faculty of Medicine, Cairo University, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: clinical pharmacist role, ICU patients, CAD patients,
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Clinical pharmacist role & ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No