PARTICIPANT INFORMATION SHEET

Evaluating the impact of upscheduling over-the-counter codeine medication in Australia: A cohort study

You are invited to participate in a research study into the impact of making codeine medication available by prescription-only in Australia. This study is being conducted by Associate Professor Raimondo Bruno (UTAS); Dr Suzanne Nielsen (UNSW), and PhD candidate Jacqui McCoy (UTAS).

Before you decide whether or not you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.

1. ‘What is the purpose of this study?’

The purpose is to investigate the impact of codeine being available by prescription-only by February 2018 on individuals who have regularly used it as an over-the-counter (OTC) medication.

This impact will be investigated by recruiting a cohort of individuals who regularly use OTC codeine to complete an online-survey at four different points in time (before and after the change). A range of measures and questions will be used to evaluate the impact including codeine use, pain management, mental and physical health and the use of health services (e.g., seeing a GP, visiting a pharmacy).

2. ‘Why have I been invited to participate in this study?’

You are able to participate in this study if you are:

- Over 18 years old

- A regular consumer of over-the-counter codeine products (e.g., Nurofen Plus, Panadeine, Mersyndol, Mersyndol Day Strength, Fiorinal, Codalgin, Aspalgin, Panafen Plus)

- Living in Australia

- Not currently engaged in treatment for codeine dependence

3. ‘What if I don’t want to take part in this study, or if I want to withdraw later?’

Participation in this study is voluntary and your consent is required to participate. It is completely up to you whether or not you participate. You do not have to answer any question you are not comfortable answering. If you wish to withdraw from the study once it has started, you can do so at any time without having to give a reason. It is important to note that once your data has been de-identified, it will not be possible to exclude it from the study.

4. ‘What does this study involve?’

This study involves completing a few initial screening questions to assess your eligibility to participate and providing basic contact details (name, phone number and email address).

Participants who are assessed as eligible will receive an email invitation to participate in this cohort study that will be conducted over a 12-month period and involves the completion of an online survey at four different time points (November 2017, February 2018, June 2018 and September 2018).

The online survey takes approximately 30 minutes to complete and involves questions around your current codeine use (OTC and prescription), any concerns or problems associated with your codeine use (e.g., difficulty going without it), your current pain management and physical and mental health.

As this cohort study is conducted at multiple time points, participant contact details (e.g., first and last name, a contact number and current email address) will be requested to enable researchers to maintain contact. These contact details will be stored separately and securely from survey responses.

In recognition of time taken to complete this survey, participants invited to complete the full survey will have the opportunity win one of twenty $100 vouchers at the first survey (November 2017) and earn $20 for completion of the survey at the second, third and fourth time points (February 2018, June 2018 and September 2018). To receive reimbursement, participants will be required to leave contact details that will be stored separately to their survey responses. If you agree to participate in this study, you will be asked to indicate that you have read this study information and give consent before participating.

5. ‘Are there risks to me in taking part in this study?’

There are minimal risks associated with this study. It is acknowledged that questions around concerns or problems with current codeine use, pain management, physical and mental health may cause discomfort for some individuals. If you might be at risk of discomfort and are concerned about participating in this survey, please do not participate. Alternatively, if you are concerned and require clarification, please do not hesitate to contact researcher Associate Professor Raimondo Bruno (contact details are at the end of this page).

If you become concerned or need to talk further with a trained support person, 24-hour telephone counselling services are available:

Lifeline is a national charity providing all Australians experiencing a personal crisis with access to 24 hour crisis support - 13 11 14 (available 24 hours, 7 days a week)

is a national charity providing all Australians experiencing a personal crisis with access to 24 hour crisis support - 13 11 14 (available 24 hours, 7 days a week) Health Direct (Australian Government) provides safe, practical health information and advice - 1800 022 222 (available 24 hours, 7 days a week).

If you have an emergency, please phone emergency services 000.

6. ‘Will I benefit from the study?’

This study aims to further awareness around codeine restriction in Australia and the impact this will have on individuals who regularly use codeine. This study may provide insight into where further education, monitoring and intervention are needed in light codeine moving to prescription-only; however, it may not directly benefit you.

7. ‘Will taking part in this study cost me anything, and will I be paid?

Participation in this study will not cost you anything. For the first survey, participants have the opportunity to win one of twenty $100 vouchers from the first survey. For the remaining three time points, you will be reimbursed $20 for your time.

8. ‘How will my confidentiality be protected?’

By submitting a completed survey, you are indicating your consent for the research team to collect and use information about you for the research study.

The survey will be administered via REDcap, a secure web application for building and managing online surveys and databases. Data collected from REDcap will be stored internally on a server on the University of Tasmania, Sandy Bay Campus. Data will be stored on password-protected servers. Only the survey creators (our research team) and UTAS server administrators will have access to this data.

We will store information about you in a de-identified format (i.e., personal information such as email address stored separately from your data) on a secure server. Your information will only be used to evaluate the impact of codeine being rescheduled to prescription only and no individual data will be published. We will compare unique identifiers from participant responses at four time points; no other information will link the data.

Following completion of the research project, data will remain stored on UTAS servers for 7 years. Personal information will be deleted approximately one month after the conclusion of the study (October 2018).

9. ‘What happens with the results?’

If you give us your permission by indicating that you provide consent, we plan to discuss/publish the results in peer-reviewed journals, at appropriate academic conferences or other professional forums. In any publication, information will be provided in such a way that you cannot be identified. Results of the study will be provided to you, if you wish.

10. ‘What should I do if I want to discuss this study further before I decide?’

If you require further information regarding this study or if you have any problems that may be related to your participation in this research project, you can contact the following member of the research team:

Associate Professor Raimondo Bruno

+61 3 6226 2240

Raimondo.Bruno@utas.edu.au

11. ‘Who should I contact if I have concerns about the conduct of this study?’

If you have concerns or complaints about the conduct of this study, please contact the Human Research Ethics Committee (HREC):

Human Research Ethics Committee Officer

+61 3 6226 7479

human.ethics@utas.edu.au

HREC project number: H0016685

If you wish to take part in it, please indicate your consent and proceed with the online survey.