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

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

doi:10.1186/s13063-020-04481-1

Cited by 7 publications

(6 citation statements)

References 34 publications

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“…Continuing education programs, communication, and relationships with other health professionals are key-factors to improve these competencies and, consequently, to achieve optimal patient medication management. Clinical trials are now seeking to establish whether a continuing education program for correct use of drugs with fiscalized substances improves the skills of the pharmacy staff concerning these drugs 36 .…”

Section: Discussionmentioning

confidence: 99%

Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies

et al. 2021

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OBJETIVE To evaluate the skills and practices of pharmacy staff during the dispensing of tramadol (drug with fiscalized substance) in drugstores and pharmacies in Medellin, Colombia. METHODS A cross-sectional study was performed. The simulated patient technique was used. The main outcomes included the information provided on the dispensed drug (tramadol), the use of tools to provide information, and the information provided on drug precautions and use recommendations. RESULTS We visited 305 drugstores and pharmacies. The average dispensing time was 2.3 min (SD 1.1 min). In nine drugstores and pharmacies (3.0%), tramadol was not dispensed because it was not in stock. In 17 drugstores and pharmacies (5.7%), the simulated patients were actively informed by the dispensing pharmacy staff; of these, 16 provided oral information and one provided oral and written information. Eight patients (2.7%) received information regarding tramadol use. However, 99% of patients were not informed about tramadol side effects such as dependence, sedation, or hypnosis, and none of the simulated female patients were informed on the precautions related to tramadol use during pregnancy or lactation. CONCLUSIONS Communication skills and appropriate practices of pharmacy staff are critical to patient self-care. However, this study shows their difficulty in counseling about precautions and use recommendations of drugs with fiscalized substances. These outcomes could inform future studies focusing on the rational use of these drugs in drugstores and pharmacies. It is necessary to improve the pharmacy staff competencies through continuing education programs, to facilitate access to information and training.

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Section: Discussionmentioning

confidence: 99%

Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies

et al. 2021

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“…The trial protocol was registered on ClinicalTrials.gov (Identifier NCT03388567), and the study methods were detailed in a previous publication of the study protocol. 18 …”

Section: Methodsmentioning

confidence: 99%

Effectiveness of a continuing education program of drugs with fiscalized substance to improve pharmacy staff competencies: a multicenter, cluster-randomized controlled trial

Ceballos¹,

Salazar-Ospina²,

Sabater‐Hernández³

et al. 2022

PHARMPRACT

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Background: Drugs with fiscalized substances without a correct prescription may lead to undesirable side effects. Pharmacy staff needs to improve their competencies (knowledge, skills, and attitudes) to contribute to providing ambulatory pharmacy services and minimizing medication errors. Continuing education programs (CEP) could favor access to relevant and quality information on health promotion, disease prevention, and the rational use of drugs. Objective: To evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies to enhance the use of drugs with fiscalized substances. Methods: A multicenter, prospective, parallel-group, cluster-randomized, controlled clinical trial was conducted in drugstores and pharmacies in Colombia (ambulatory retail establishments). The intervention group (IG) received a CEP: a web-based social networking site, a virtual course, a dispensing information system, and face-to-face training. The control group (CG) received general written material on the correct use of drugs. We measured pharmacy staff's skills, attitudes, and knowledge self-reported scores, and the simulated patient technique was used to assess the participant skills and attitudes in real practice. We used a questionnaire designed for this study, which was evaluated by a group of experts and piloted and showed a Cronbach's alpha of 0.96. Results: Three hundred five drugstores and pharmacies were enrolled in two groups: IG (n = 153) and CG (n = 152). Out of the 750 potential participants, 88% (n=659) agreed to participate. The pharmacy staff's skills, attitudes, and knowledge self-reported scores post-intervention were higher than baseline in both groups; however, the IG had statistically significantly higher scores than the CG. Post-intervention, the self-efficacy skills and attitudes in the IG improved by 88% (22 of 25) and in six of the seven assessed knowledge components (p<0.001). However, the dispensing criteria evaluated with simulated patient methodology showed no statistically significant differences between groups in the pharmacy staff's skills and attitudes in real practice. Conclusions: Providing a continuing education program using different educational strategies improved the pharmacy staff's competencies (assessed knowledge and self-reported skills and attitudes) to enhance the use of drugs with fiscalized substances. However, there were no improvements in skills and attitudes in real practice. These findings could show that pharmacy staff needs additional and continuous training/sustainability.

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“…45 - 49 Nevertheless, there are challenges including the training and educating of persons working in drugstores and pharmacies with objective in improving the rational use of medicines in these establishments. 38 …”

Section: Opportunities For the Integration Of Community Pharmacymentioning

confidence: 99%

“…Due to the combination of worker profiles in retail pharmacy establishments, the term "pharmacy staff" (person working in drugstores and pharmacies, and whose educational level may be a professional, technician, technical/auxiliary or with and without a certificate) is broad. 38 In Colombia, over 50% of retail pharmacy establishments (drugstores and pharmacies) may have owners or employees without university education and training necessary to work as a pharmacist. 24,25,29 One of the current NPP's strategic lines establishes the need to train and educate persons in drugstores and pharmacies to contribute to the rational use of medicines.…”

Section: Pharmacy Education and Workforcementioning

confidence: 99%

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Primary health care policy and vision for community pharmacy and pharmacists in Colombia

Amariles

Ceballos

Gonzalez-Giraldo

2020

Pharm Pract (Granada)

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Colombia is a decentralized republic with a population of 50 million, constituted by 32 departments (territorial units) and 1,204 municipalities. The health system provides universal coverage and equal access to health care services to 95% of the population. Primary health care is seen as a practical approach that guarantees the health and well-being of whole-of-society. The National Pharmaceutical Policy (NPP, 2012) goal is "to develop strategies that enable the Colombian population equitable access to effective medicines, through quality pharmaceutical services (PS)”. There are 4,351 providers certified to deliver PS: 3,699 (85%) ambulatory and 652 (15%) hospital care. The goals for PS are: a) promoting healthy lifestyles; b) preventing risk factors arising from medication errors; c) promoting rational use of medicines; and d) implementing Pharmaceutical Care. There are a number of ways that ambulatory patients access medications: through intermediary private companies, public and private hospitals pharmacies, and retail establishments (drugstores and pharmacies). Intermediary private companies are similar to Pharmaceutical Benefits Management in the U.S. health system, and act as intermediaries between health insurers, pharmaceutical laboratories, and patients. Pharmacists are being employed by these companies and in health insurance companies managing, auditing and delivering rational use of medicines programs. In 2014 there were approximately 20,000 pharmacies and drugstores, (private establishments) where a significant number of prescription-only medicines are sold without medical prescription. Colombian laws allow personal without pharmacy education to be a “director” in these establishments, so the training and education of persons working in drugstores and pharmacies is an important challenge. There about 8,000 registered pharmaceutical chemists with 25% to 30% working in patient care. Since the 90´s, there are more favorable conditions for pharmacist’s participation and contribution to health system and patient’s health outcome. These environmental facilitators include: a) laws and regulations regarding pharmaceutical services (2005-2007), b) establishment of a NPP (2012), and c) opportunities associated with the consolidation of private health management companies providing health services with an interest in pharmaceutical services (since 1995). Finally, telepharmacy, comprehensive care routes for pharmaceutical services, and further strengthen of postgraduate training in pharmacy practice are future strategies to improve the pharmacy profession in Colombia. They provide an opportunity to influence the recognition and value of the pharmacist as the health care professional.

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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

Cited by 7 publications

References 34 publications

Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies

Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies

Effectiveness of a continuing education program of drugs with fiscalized substance to improve pharmacy staff competencies: a multicenter, cluster-randomized controlled trial

Primary health care policy and vision for community pharmacy and pharmacists in Colombia

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