Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments
- Conditions
- Community Pharmacy Services
- Interventions
- Other: Patient guided and followed by the pharmacist
- Registration Number
- NCT06378099
- Lead Sponsor
- Universidad de Antioquia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Patient guided and followed by the pharmacist Patients will be guided and followed by the pharmacist. This group will have four activities: 1. Classification and presence of the MA, 2. Referral to a physician for the presence of a non-MA, 3. Patient guidance on pharmacological measures in case an OTC medication is required 4. Identification of ADRs associated with the use of OTC medications or worsening of the MA and referral to a physician. For each MA, the Pharmacist will request the patient's Informed Consent, apply what is described in Activities 1, 2, and 3, and fill in the instrument included in Annex 4. Days 3 to 5, 5 to 6, 7 to 10, and 10 to 12 will be followed as described for control group.
- Primary Outcome Measures
Name Time Method Resolution time of the MA and the frequency of referral to a physician. 12 months 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).
- Secondary Outcome Measures
Name Time Method Need to acquire an OTC medication to treat the MA 12 months 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
Characterization of the population visiting drugstore or drugstore/pharmacy 3 months 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.
Identification of the presence and classification of the MA 12 months 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.
Trial Locations
- Locations (1)
Farmacias Pasteur S.A.
🇨🇴Medellin, Antioquia, Colombia