Role of Clinical Pharmacists in Epilepsy Management

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

Number of patients with two seizures or less

Time frame: One year from the start of the study

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.

Secondary outcomes

Number of patients who maintained an optimized concentration of antiepileptic drugs

Time frame: One year from the start of the study

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.

Sponsors and collaborators

Lead sponsor

Gia Dinh People Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jul 19, 2021
Registry last updated: Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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