Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments

Phase

N/A

Condition

N/A

Treatment

Patient guided and followed by the pharmacist

Clinical Study ID

NCT06378099

CBP Colombia

Ages 18-65
All Genders

Study Summary

Minor ailments are common, self-limited conditions unrelated to the patient's underlying health problems or adverse effects of their current medications. Minor ailment services are pharmacist-led interventions that provide patients with the most appropriate recommendation when unsure about the medication for a specific minor ailment. It involves advice on nonprescription drugs, non-pharmacological measures, or referral to another health care practitioner. In Colombia, evaluating and implementing this service could optimize nonprescription drugs use and improve minor ailment management in primary health care settings.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Drugstores and drugstores/pharmacies:

Establishments located in Medellin and Metropolitan area
Establishments that have a Pharmacy Technician serving as the technical director.
Establishments with electronic point-of-sale system for data collection.
Commitment to participate for the full 10-month study period.

Participants (patients):

Explicit consent to participate in the study.
Are the direct consumers requesting the nonprescription drug (i.e., not requestingthem on behalf of someone else).
Present one of the five predefined potential MA that will be included in the study:influenza-like syndrome and catarrh, headache, common cold, sore throat, andmenstrual pain or cramps.
Have access to mobile phone for follow-upThe person requesting the OTC medicationmust be the end consumer of it.

Exclusion

Exclusion Criteria:

Subjects who refuse to sign the informed consent
Subjects with an evident incapacity to complete the data questionnaire
Pregnant or breastfeeding women
Patients whose MA result from an ADR
Patients with symptoms lasting more than seven days

Study Design

Patient guided and followed by the pharmacist

December 04, 2024

October 31, 2025

Study Description

A 10-month parallel-group clinical trial will be conducted in drugstores and pharmacies (ambulatory retail establishments) in Medellín and the Metropolitan Area. Patients requesting nonprescription drugs for one of five predefined minor ailments (influenza-like syndrome, common cold, headache, dysmenorrhea, or sore throat) will be eligible. Establishments, randomized by cluster sampling, will be allocated to either the intervention (management using CBPs) or control (standard management + education on responsible self-medication) group. Pharmacy staff will receive training in appropriate CBP use. Eligible patients will be consecutively enrolled and followed-up by the research team on days 3, 5, 7, and 10 after the consultation in both groups. Analyses will be performed using Python, including descriptive statistics, bivariate comparisons (p < 0.05), and multivariate Cox regression for significant variables. An intention-to-treat approach will address missing data and dropouts.

The aim of this study is to evaluate the effect of Consensus-based Protocols (CBPs) on the management and duration of some MA, and on the referral rate to General medical Practitioner (GPs) in drugstores and pharmacies. Secondary outcomes include: 1) To clinically and socio-demographically characterize the population that visits a drugstore or pharmacy requesting a nonprescription drug to manage a MA, and 2) To assess the management, duration, rate and causes of GP referrals in drugstores and pharmacies with the use of CBPs among patients requesting nonprescription drugs for the management of a potential MA.

Connect with a study center

Farmacias Pasteur S.A.
Medellin, Antioquia 050001
Colombia
Site Not Available
Farmacias Pasteur S.A.
Medellín 3674962, Antioquia 3689815 050001
Colombia
Active - Recruiting

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