Role of Clinical Pharmacists in Epilepsy Management

Epilepsy Clinical Trial

Official title:

Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967326
• Other study ID #: 23-2015/CN-HÐÐÐ
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2021
• Source: Gia Dinh People Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.

Description:

Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.

However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.

• were treated for more than one month.

Exclusion Criteria:

• were pregnant or breastfeeding women.

• had a history of alcoholism.

• had liver or renal disease.

• were using drugs known to have an influence on cytochrome P450 enzymes.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with two seizures or less	Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.	One year from the start of the study
Secondary	Number of patients who maintained an optimized concentration of antiepileptic drugs	The targeted therapeutic ranges for carbamazepine, phenytoin, and valproic acid were 4-12 mg/L, 10-20 mg/L, and 50-100 mg/L, respectively.	One year from the start of the study