Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments

Last updated: April 29, 2025
Sponsor: Universidad de Antioquia
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Patient guided and followed by the pharmacist

Clinical Study ID

NCT06378099
InFaPro
  • Ages 18-65
  • All Genders

Study Summary

Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols.

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.

Participants (patients):

  • Explicit consent to participate in the study.

  • The person requesting the OTC medication must 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

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Patient guided and followed by the pharmacist
Phase:
Study Start date:
December 04, 2024
Estimated Completion Date:
October 31, 2025

Study Description

This study is an experimental investigation with a baseline reference period, involving parallel groups of patients who approach a drugstore or drugstore/pharmacy to purchase over-the-counter medication for the treatment of a possible minor ailment. Drugstores or drugstores/pharmacies will be selected using cluster sampling, and patients will be randomly allocated to one of the study groups (intervention or control). The intervention group will receive care in line with the consensus pharmaceutical indication protocols and will undergo follow-up on days 3, 5, 7, and 10 post-care; the control group will continue with the standard care procedure. The aim of this study is to assess whether the implementation of consensus pharmaceutical indication protocols can shorten the resolution time of minor ailments and reduce the frequency of referrals to physicians. Secondary outcomes include: 1) profiling the population that visits a drugstore or drugstore/pharmacy to purchase an over-the-counter medication for a minor ailment, 2) identifying and classifying the minor ailment, 3) determining the necessity for over-the-counter medication to address the minor ailment, and 4) improvement, time to improvement, and frequency and causes of medical referral among this population.

Connect with a study center

  • Farmacias Pasteur S.A.

    Medellin, Antioquia 050001
    Colombia

    Active - Recruiting

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