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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03388567
Enrollment
360
Registered
2018-01-03
Start date
2018-12-01
Completion date
2019-12-31
Last updated
2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Controlled Drug Dependence

Keywords

Dispensation, Health Education, Pharmacovigilance, Pharmacists

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).

Interventions

OTHERStaff pharmacy whith intervention

Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist

Sponsors

Universidad de Antioquia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

study protocol for a multicenter, cluster-randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )12 monthsPharmacy 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 %)

Secondary

MeasureTime frameDescription
Characterize the processes associated with the use of medications in the Pharmaceutical Establishments2 monthsRecognize 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 %)
Implementation of pharmaceutical professional services12 monthsMeasure 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 %)
Satisfaction level pharmacy staff12 monthsPharmacy 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.
Satisfaction level patients12 monthsPatients 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

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026