Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies

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

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.

Study Overview

• Status: Completed
• Conditions: Controlled Drug Dependence
• Intervention / Treatment: Other: Staff pharmacy whith intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 1226
      • Universidad de Antioquia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Staff pharmacy whith intervention; Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist	Other: Staff pharmacy whith intervention; Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
No Intervention: Staff pharmacy without intervention; Staff pharmacy who will receive only pharmacy information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )	Pharmacy staff knowledge, skills and attitudes. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for pharmacy staff competences. The main areas of competency (competency clusters): which are: Delivery of patient care; Personal; Problem Solving; Management and Organisation The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently: Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %); Sometimes: Much more haphazard than "usually" (21-50 %); Usually: Implies standard practice with occasional lapses (51-84 %); Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the processes associated with the use of medications in the Pharmaceutical Establishments	Recognize basic information of the Pharmaceutical Establishments (PE), to characterize some processes related to the use of controlled drugs (CD), including compliance with the regulations, and determine the level of risk perception and the continuing education needs of the pharmacy staff. An adapted and self-designed questionnaire is used from different bibliographical references. The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently: Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %); Sometimes: Much more haphazard than "usually" (21-50 %); Usually: Implies standard practice with occasional lapses (51-84 %); Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)	2 months
Implementation of pharmaceutical professional services	Measure the degree of implementation of pharmaceutical professional services: Dispensation, Health Education and Pharmacovigilance services. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the guidelines of the Colombian legislation for the development of pharmaceutical services. The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently: Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %); Sometimes: Much more haphazard than "usually" (21-50 %); Usually: Implies standard practice with occasional lapses (51-84 %); Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)	12 months
Satisfaction level pharmacy staff	Pharmacy staff satisfaction about the continuing education program. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for the development of labor competences from the pharmaceutical services. A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire.	12 months
Satisfaction level patients	Patients satisfaction of pharmacy professional services. An adapted and self-designed questionnaire is used from different bibliographical references. A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire	12 months

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Investigators: Principal Investigator: Pedro Amariles, PhD, Universidad de Antioquia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 24, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Health Education; Pharmacists; Pharmacovigilance; Dispensation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 0017102017MC

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