What is the CLEAN Meds study, and why is it being done?
The CLEAN Meds research project will measure the effects of providing primary care patients with access to essential medications for free. This project is being done because there are Canadians who have difficulty affording medications. We would like to determine the health effects of providing people with free and convenient access to medications.
What are the implications for patients enrolled in the study?
Half of enrolled patients will be randomly assigned to the group that gets free and convenient access to essential medications, and half will be assigned to a control group with usual access to medications. Participants in the first group will receive the medications through the mail from a research pharmacy (or, in the case of medications that need to be started the same day, by dispensing in clinic by the prescriber). All participants will be asked to complete surveys throughout the study and some will receive medications in special bottles that allow tracking of medication adherence.
How was the list of essential medications developed?
The list of essential medications started by taking the list of essential medicines published by the World Health Organization and adapting it to primary care in Canada through peer review by clinicians across Canada.
What are the implications for prescribers (family physicians and nurse practitioners)?
Prescribers will identify potential participants and connect potential participants with the site research assistant. Prescribers may be asked about medication changes by the research pharmacist and sometimes responses will be needed before medications can be dispensed. For medications that need to be started right away, prescribers will ultimately be responsible for dispensing although they will have support from the research assistant. Prescribers should report all serious adverse events or medication incidents to the research pharmacist.
What are the implications for other clinic staff?
Clinic staff should be aware of the study and help prescribers identify potential participants. Staff should also know that participants will have another pharmacist and pharmacy that will be dispensing study medications.
What are the implications for the leadership of participating sites?
The clinical and administrative leaders at each site will help facilitate the conduct of the study by supporting the research assistant and prescribers with adequate time and space for study activities.
What are the implications for specialists or consultants?
Medical specialists and consultants (e.g., cardiologists, psychiatrists) should be notified of study participation. Each participant will be provided with a post card with the contact information for the research team and the research pharmacy. Participants can show this to the specialist, who can then go to the website to check the list, and send a prescription to the research pharmacy. This also allows the research pharmacist to update the primary care team about new medications for the patient.
What will be done with the results?
The results will be published in a medical journal and presented at conference. We expect public and media interest in the findings. We hope the findings will help inform discussions about medication access policy discussions including discussions of pharmacare.
What approvals have been obtained?
The project has been approved by Research Ethics Boards or Committees for St Michael’s Hospital, Laurentian University and the Huron Shores Family Health Team.
How is the CLEAN Meds study funded?
The CLEAN Meds study is funded by the Government of Canada and the Government of Ontario through an IMPACT research grant (Innovative, Measurable, Patient-oriented, Appropriate, Collaborative and Transformative) from the Ontario Supporting Patient Oriented Research Support Unit and by the St Michael’s Hospital Foundation. There is no funding from pharmaceutical companies; the research grant is paying for the medications.
Who should I contact with questions?
You can contact the study team including the research pharmacist by calling 1-888-919-1114. You can contact the principal investigator, Dr Nav Persaud by email to email@example.com.