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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )
时间窗: 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 %)
次要结局
- Characterize the processes associated with the use of medications in the Pharmaceutical Establishments(2 months)
- Implementation of pharmaceutical professional services(12 months)
- Satisfaction level pharmacy staff(12 months)
- Satisfaction level patients(12 months)
研究者
Pedro Amariles
Investigador principal
Universidad de Antioquia