Clinical trial NCT06378099: Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community Pharmacy Services
Keywords: Pharmaceutical indication
Pharmacist
Drugstore
Drugstore/pharmacy
Minor ailments
Over-the-counter medication
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Farmacias Pasteur
First posted: 2024-04-22
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An exploratory clinical trial with a baseline reference period of parallel groups will be conducted. The study will take place over a period of 10 months, during which 5 MA will be analyzed, and for each of them, patients will be followed up on days 3, 5, 7, and 10 post-care (intervention). Drugstores and drugstores/pharmacies (groups) will be randomized in a 1:1 ratio to enroll in the intervention group or the control group.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution time of the MA and the frequency of referral to a physician.
timeFrame: 12 months
Secondary outcomes:
measure: Characterization of the population visiting drugstore or drugstore/pharmacy
timeFrame: 3 months
measure: Identification of the presence and classification of the MA
timeFrame: 12 months
measure: Need to acquire an OTC medication to treat the MA
timeFrame: 12 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Farmacias Pasteur S.A.
state: Antioquia
Study officials:
References: