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Completed

NCT Number: NCT03388567

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

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.

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Key information

Conditions

Controlled Drug Dependence Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Antioquia

Medellín, Antioquia, 1226, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Inclusion Exclusion:

  • Pharmacy staff who do not agree to participate in the study

Treatment and study plan

Staff pharmacy whith intervention

Other

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

Primary outcomes

  1. Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )

    Time frame: 12 months

    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 %)

Secondary outcomes

  1. Characterize the processes associated with the use of medications in the Pharmaceutical Establishments

    Time frame: 2 months

    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. Implementation of pharmaceutical professional services

    Time frame: 12 months

    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 %)

  3. Satisfaction level pharmacy staff

    Time frame: 12 months

    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.

  4. Satisfaction level patients

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 3, 2018
Registry last updated
Apr 10, 2020

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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