Controlled Drug Dependence Clinical Trial
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
| Verified date | April 2020 |
| Source | Universidad de Antioquia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 360 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 1, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Universidad de Antioquia | Medellín | Antioquia |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad de Antioquia |
Colombia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |