Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments
Evaluation of the Effect of Consensus-based Protocols for the Treatment of Minor Ailments in Drugstores and Pharmacies in Medellin and the Metropolitan Area, Colombia: A Randomized Clinical Trial.
Universidad de Antioquia
900 participants
Dec 4, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- Drugstores and drugstores/pharmacies:
- 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.
- Participants (patients):
- Explicit consent to participate in the study.
- Are the direct consumers requesting the nonprescription drug (i.e., not requesting them on behalf of someone else).
- Present one of the five predefined potential MA that will be included in the study: influenza-like syndrome and catarrh, headache, common cold, sore throat, and menstrual pain or cramps.
- Have access to mobile phone for follow-upThe person requesting the OTC medication must be the end consumer of it.
Exclusion Criteria5
- 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
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Interventions
The 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.
Locations(1)
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NCT06378099