The study protocol was registered and published on ClinicalTrials.gov (identifier: NCT03388567) and the study methods were described in detail in a previous publication of the study protocol .
Study design and setting: This multicenter, prospective, parallel-group, cluster-randomized, controlled clinical trial was conducted in Medellin and the Metropolitan Area (Colombia) drugstores and pharmacies (Figure 1). We developed a 12-month intervention delivery and follow-up (September 2018 to September 2019). Drugstores and pharmacies (the clusters) were randomized at a 1:1 ratio to enroll in either the intervention or control group. The geography zone (neighborhoods) was randomized stratified. For the method design, the Consolidated Standards of Reporting Trials (CONSORT) recommendations were followed.
Study population and recruitment: We identified the drugstores and pharmacies in a cross-sectional epidemiological study on utilizing drugs with fiscalized substances in 2016 . We invited the pharmacy staff (professional, technician, technical/auxiliary or with and without a certificate) of 700 drugstores and pharmacies to participate in the study. The trial recruited at least one pharmacy staff member from each drugstore or pharmacy.
Sample size: The continuing education program was expected to improve the pharmacy staff competencies in the intervention group by at least 30% and in the control group by 15%. Considering the educational intervention findings rises in 37% of the competencies . Therefore, with a confidence level of 95% and a power of 80%, it was calculated at least 121 drugstores and pharmacies in each group. The sample was increased by 10% to cover losses to follow-up, increasing the sensitivity; the final selection size was 135 drugstores and pharmacies, for each group.
Allocation and blinding: Group allocation (intervention group or the control group) was blinded. Blinding of pharmacy staff was not possible because of the nature of the intervention. Patients and caregivers were blinded because they did not receive the given details of the intervention.
Intervention: Continuing education program: The continuing education program was made with different and independents actions executed transversely during their implementation and follow-up (12 months: September 2018 to September 2019).
- Web-based social networking sites and access to a virtual classroom: The Web-based social networking site's access and interactivity were continuous 24 hours a day, 7 days a week. The pharmacy staff accessed from personal computers and mobile touch screen devices, sharing their status with the community to establish communication with others.
- Virtual course: The virtual course was designed using Moodle 3.3.2+, and composed of 7 modules: 1) Pharmaceutical terminology and basic pharmacology, 2) Pharmaceutical legislation, 3) Administrative and technical activities related to supply of medicines in pharmacies, 4) Communication and health education from the pharmacy, 5) Good practices of dispensation and correct use of drugs, 6) Pharmacovigilance from the pharmacy, and 7) Pharmaceutical actuation of some common diseases in the pharmacy and, in which drugs with fiscalized substances are used (depression, anxiety, sleep disorders, and pain management). Each module's study time required an average of 20 hours of study (10 hours synchronous and 10 hours asynchronous), for a total of 140 hours of virtual course.
- Drug information and dispensing system: The software had three main components: dispensing, pharmacovigilance, and pharmaceutical care. The pharmacy staff entered patient personal information, health problems, and information about the drugs. The general information for the utilization of proper drugs with fiscalized substances that patients use could be accessed. The pharmacy staff could refer (reference) the patient to the principal investigator of the study (professional pharmacist) to conduct counseling, education, or pharmaceutical care.
- Pharmacy staff training: All the intervention group pharmacist staff were invited to participate in five face-to-face training to complement the virtual course contents. Each session was last 4 hours, for a total of 20 hours of face-to-face training.
Control group: Pharmacy staff in the control group received during the follow-up time written material on the correct use of complex dosage forms.
Strategies to improve adherence to protocol: The pharmacy staff received phone calls from one of the researchers to encourage compliance with the protocol, solve questions, and provide technical support. Each module of the virtual course completed by pharmacy staff was certificated.
Outcomes: Pharmacy staff competencies were assessed using two self-applied questionnaires: One questionnaire of 50 multiple-choice questions for the knowledge and the skills and attitudes, and another questionnaire of 100 questions with four possible options: never, sometimes, usually, or always. The measurements were performed baseline (T0) before the intervention and 12 months (1-year) after completing the follow-up (T12). Additionally, the simulated patient technique was used to evaluate the pharmacy staff's skills and attitudes in the dispensation and the information provide for the correct use of tramadol (drugs with fiscalized substance).
Simulated patient technique: Simulated patient methodology is an effective tool or method that evaluates aspects in providing health care services to patients and is provided by pharmacy staff in actual practice. This research methodology has demonstrated its validity and reliability in investigating the practice of healthcare pharmacy . Twenty simulated patients were trained to be representing and act coherently and accurately predetermined disease and treatment, specifically back pain and use of tramadol by medical prescription. The simulated patients signed informed consent to guarantee the confidentiality of the information collected. The pharmacy staff did not know at any time that the patient was simulated. The indicators evaluated were the average time of dispensing, the availability of tramadol stocks, the specific process for a first dispensing, the use of tools and materials to provide information, important safety information (absolute contraindications and most frequent adverse drug reactions) and recommendations for correct use, including the importance of adherence therapy. Additionally, following the Good Dispensing Practices , the simulated patients were trained to evaluate the dispensing process at the end of each visit as good, regular, or bad .
Statistical methods: Baseline and demographic characteristics were analyzed descriptively.
For between-group comparisons, the Chi-square test (or the Fisher exact test when appropriate) was conducted for comparisons categorical variables, and continuous variables used the independent sample t-test or the Mann-Whitney U test. We used the McNemar test for pre-post analyses to evaluate the difference in the competency’s questionnaire of skills/attitudes and the Wilcoxon test for the knowledge questionnaire scores. All statistical tests were computed using the Statistical Package for the Social Sciences (version 23; SPSS, Chicago, Ill., USA) with significance defined as a p<0.05.