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

Community Pharmacy Services Clinical Trial

— InFaPro  

Official title:

Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments in Drugstores and Drugstores/Pharmacies in Medellin and the Metropolitan Area, Colombia: InFaPro, a Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378099
• Other study ID #: InFaPro
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Universidad de Antioquia
• Contact: Andrea Salazar
• Phone: +573017971909
• Email: asalazarospina[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 to 5, and 7 to 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, and 3) determining the necessity for over-the-counter medication to address the minor ailment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Community Pharmacy Services

Intervention

Other:
• Patient guided and followed by the pharmacist
The Study Coordinating Group will train the pharmacy Staff regarding these protocols. The training will include both pharmacological and non-pharmacological aspects of managing MA. In the pharmacological component, emphasis will be placed on the appropriate selection of OTC medications to address different MA, with special attention to identifying potential drug interactions, contraindications, and potential ADRs. Tools will also be provided to advise patients on the correct and safe use of these medications, and the criteria for referral to a physician. The staff will be divided into three groups, and every group will have a minimum of two sessions, each one of 4 hours. Additionally, there will be a practical component where simulations of real situations will be conducted. Throughout the 12-month follow-up and intervention period, one of the researchers will be available to receive phone calls to address doubts and concerns about the Pharmaceutical Indication Protocol.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Farmacias Pasteur

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution time of the MA and the frequency of referral to a physician.	The resolution time of the MA and the frequency of referral to a physician, both due to worsening of the MA or appearance of ADR, will be assessed through three self-administered questionnaires, which will be conducted at the beginning (T0) before the intervention, three days after the intervention (T3), and seven days after the intervention (T7).	12 months
Secondary	Characterization of the population visiting drugstore or drugstore/pharmacy	Characterization of the population visiting the drugstore or drugstore/pharmacy to purchase an OTC medication for treating a MA. Measurements will be taken only at baseline (T0) before the intervention.	3 months
Secondary	Identification of the presence and classification of the MA	Identification of the presence and classification of the MA. Measurements will be taken in both groups (control and intervention) at baseline (T0) before the intervention; the difference lies in the fact that in the control group, the patient themselves will identify and classify the MA, while in the intervention group, this identification and classification will be done by the pharmacist.	12 months
Secondary	Need to acquire an OTC medication to treat the MA	Need to acquire an OTC medication to treat the MA. Measurements will be taken in both groups (control and intervention) at baseline (T0); the difference lies in the fact that in the intervention group, the need will be guided by the pharmacist and according to the consensus-based Pharmaceutical Indication Protocols	12 months