Clinical trial NCT03388567: Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
Official title: Evaluation of the Effects of a Drug With Fiscalized Substances Dispensation, Health Education and Pharmacovigilance Continuing Education Program in Community Pharmacies: Study Protocol for a Multicenter, Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Controlled Drug Dependence
Keywords: Dispensation
Health Education
Pharmacovigilance
Pharmacists
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study protocol for a multicenter, cluster-randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the Medication Supply System (availability and quality).

The controlled drugs are those that contain substances regulated by international conventions on drug control. They are important in various fields of medicine, such as pain management, obstetric emergencies, mental disorders such as the treatment of substance dependence, psychiatry and neurology. It has been defined as abuse of drugs the improper use of these for non-medical purposes, and associated with the use without medical prescription, which can produce addiction or psychic or physical dependence.

Detailed description: Experimental study with random assignment of the staff pharmacist of Pharmacies. The staff pharmacists admitted will be followed for 12 months (1 year). The study will make it possible to determine the effect of the continuing education program accompanied by Information and Communication Technologies (ICT).

Eligibility criteria: Inclusion Criteria:

1. Pharmacy staff working in Pharmacy or Drugstore, located geographically in the city of Medellín and in the Metropolitan Area
2. That the owner works in the establishment

Inclusion Exclusion:

1. Pharmacy staff who do not agree to participate in the study

Primary outcomes:
measure: Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )
timeFrame: 12 months
Secondary outcomes:
measure: Characterize the processes associated with the use of medications in the Pharmaceutical Establishments
timeFrame: 2 months
measure: Implementation of pharmaceutical professional services
timeFrame: 12 months
measure: Satisfaction level pharmacy staff
timeFrame: 12 months
measure: Satisfaction level patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Pedro Amariles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ceballos M, Salazar-Ospina A, Sabater-Hernandez D, Amariles P. Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial. Trials. 2020 Jun 19;21(1):545. doi: 10.1186/s13063-020-04481-1.