Evidence map›Paper›PMID 32560735›Full record

ArticleTrials2020

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.

Mauricio Ceballos, Andrea Salazar-Ospina, Daniel Sabater-Hernández, Pedro Amariles

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03388567 (Evaluation of the Effects of a Drug With Fiscalized Substances Dispensation, Health Education and Pharmacovigilance Continuing Education Program in Community Pharmacies), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03388567 nacompletednot on this map

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

TypeinterventionalSponsorUniversidad de AntioquiaRan2018 to 2019Enrolled360ConditionsControlled Drug DependenceArmsStaff pharmacy whith intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 2 countries.

Mauricio CeballosResearch Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia.ORCID http://orcid.org/0000-0001-6181-7370
Andrea Salazar-OspinaResearch Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia.
Daniel Sabater-HernándezPharmaceutical Care Research Group, Faculty of Pharmacy, University of Granada, Granada, Spain.
Pedro AmarilesResearch Group on Pharmaceutical Promotion and Prevention, University of Antioquia, U.de.A. Calle 70 No 52-21, Medellin, Colombia. pedro.amariles@udea.edu.co.
Universidad de Antioquia · COUniversidad de Granada · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHealth disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including self-medication, since access to these drugs may be easier. Also, there is a lack of knowledge that these drugs are safer than illicit drugs. The use of these drugs without a valid medical prescription and follow-up can have negative consequences such as drug abuse, addiction, and overdose, and eventually, have negative health consequences. Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy. For this reason, it is necessary to increase key competencies like knowledge, skills, and attitudes in the pharmacy staff of ambulatory (outpatients) pharmacies.

methodsThis study is a prospective, cluster-randomized, parallel-group, multicenter trial of drugstores and drugstores/pharmacies (ambulatory pharmacies). The study is designed to determine the effectiveness of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in drugstores and drugstores/pharmacies. Pharmacy staff will be randomly selected and assigned to one of the study groups (intervention or control). The intervention group will receive a continuing education program for over 12 months. The control group will receive only general information about the correct use of complex dosage forms. The primary objective is to evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies (knowledge, skills, and attitudes) to improve the ambulatory (outpatient) pharmacy services: dispensation, health education, and pharmacovigilance of drugs with fiscalized substances. The secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program. DISCUSSION: This clinical trial will establish whether providing a continuing education program for the adequate utilization of drugs with fiscalized substances improves pharmacy staff competencies regarding these drugs.

trial registrationClinicalTrials.gov NCT03388567. Registered on 28 November 2017. First drugstore or drugstore/pharmacy randomized on December 1, 2018. PROTOCOL VERSION: 0017102017MC.

Indexed as

Clinical CompetenceColombiaEducation, Pharmacy, ContinuingHealth EducationHealth Knowledge, Attitudes, PracticeHumansMulticenter Studies as TopicPharmaciesPharmacistsPharmacovigilanceProspective StudiesRandomized Controlled Trials as TopicControlled drugsDispensationDrugstoresFiscalized substancesHealth educationPharmaciesPharmacovigilancePharmacy staff

Identifiers

PMID32560735
PMCPMC7304186
OpenAlexW3035939471

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.