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.
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.
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
Parallel
Patient guided and followed by the pharmacist
Other interventionThe Study Coordinating Group will train the pharmacy Staff regarding these protocols. This training will cover both pharmacological and non-pharmacological aspects of MA management. The pharmacological component will emphasize the appropriate selection and safe use of nonprescription drugs, with a focus on identifying potential drug interactions, contraindications, and moderate and serious ADRs. Pharmacy staff will also be equipped with tools to apply proper criteria for referral to a GP when necessary. 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 Consensus-based Protocols.
MA resolution
MA resolution will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. MA resolution will be recorded as a binary outcome (yes/no). This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.
MA duration
The duration of the MA will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. MA duration will be measured in days from the intervention at the drugstore or pharmacy to complete symptom resolution or if a referral to a GP is needed. This outcome is clinically relevant as it will reflect the effectiveness of the intervention with CBPs.
Referral rate to GP
Referral rate to GP, both due to symptoms worsening or occurrence of moderate or serious ADRs, will be evaluated using five self-administered questionnaires. These will be administered at baseline (T0) before the intervention, and on days 3 (T3), 5 (T5), 7 (T7), and 10 (T10) after the consultation. Based on patients' responses to follow-up questionnaires, referral to a GP will be recorded as a binary outcome (yes/no), indicating whether a referral occurred due to symptom worsening or suspected moderate or serious ADRs. This measure is relevant for evaluating patient safety and the effectiveness of the intervention with CBPs.
Characterization of the patient population visiting the drugstores and pharmacies to request nonprescription drugs for the management of a MA
Sociodemographic and clinical data (e.g., age, sex, education level, prior use of nonprescription drugs) will be collected only at baseline (T0), before the intervention. This data will help contextualize the findings and identify population-specific factors influencing outcomes.
Identification and classification of the MA
In both the intervention and control groups, the presence and type of MA will be recorded at baseline (T0). In the control group (standard management + education on responsible self-medication), the patient will self-identify and classify the MA, whereas in the intervention group (management using CBPs), this will be done by the pharmacy staff following protocolized classification criteria. The outcome is relevant to verify the presence of a MA within drugstores and pharmacies.
Need for a nonprescription drug to treat the MA
This binary variable (yes/no) will be assessed in both groups at baseline (T0) and will indicate whether the patient obtained a nonprescription drug for MA management. In the control group (standard management + education on responsible self-medication), medication selection will be driven by the patient's decision. In the intervention group (management using CBPs), this decision will be guided by the pharmacy staff in accordance with the CBPs. Clinically, this informs the appropriateness and potential rationalization of nonprescription drug use under protocol-based pharmaceutical guidance.
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Universidad de Antioquia
Lead sponsor
Farmacias Pasteur
Collaborator
