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      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Impact of Removing Nonprescription Codeine in Australia: Protocol for a Prospective Cohort Study

      research-article
      Author(s): , MClinPsych 1 , , , PhD 2 , , PhD 1
      Editor(s):
      Other contributor(s): (Reviewer), (Reviewer)
      Publication date (Electronic):
      Journal: JMIR Research Protocols
      Publisher: JMIR Publications
      Keywords: codeine, opioids, dependence, rescheduling, drug policy

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          Abstract

          Background

          On February 1, 2018, Australia rescheduled codeine to a prescription-only medication. Many concerns were associated with this change, including increased financial costs, reduced service accessibility, the potential for poorer pain management, and a decline in physical and mental health if codeine could not be accessed. In the research literature, there is limited knowledge about the long-term consequences of rescheduling pharmaceutical opioids and, as Australia has followed many countries in implementing a restriction on codeine, further study of these consequences is critical.

          Objective

          The goal of this study was to examine the impact of rescheduling codeine from an over-the-counter (OTC) product to a prescription-only medicine on the primary measures of codeine use and dependence in a prospective cohort of people who are frequent consumers of OTC codeine. Secondary measures included pain and self-efficacy, health service use, and mental health.

          Methods

          The Codeine Cohort study aimed to recruit 300 participants in Australia who regularly (at least a few times per week for the past 6 months) used OTC codeine. Using an online survey, participants were followed up at three time points (February 2018, June 2018, and February 2019) after codeine was rescheduled.

          Results

          All four waves of data collection are complete, with the final round of data collection finalized in August 2019. Data analyses are yet to be completed. Information on demographics, codeine use and dependence, physical and mental health, medication use, and health service use will be analyzed using mixed models.

          Conclusions

          Results of this study will provide insight into the effectiveness of regulatory restriction in curtailing nonmedical use of and harms associated with codeine. Additionally, results will explore positive and negative outcomes of codeine rescheduling for individual patients, which informs health professionals who support patients who use codeine and further community education.

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/15540

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          Most cited references61

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          Monitoring depression treatment outcomes with the patient health questionnaire-9.

          Bernd Löwe, Jürgen Unützer, Christopher M Callahan … (2004)
          Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring, an efficient method for assessing treatment outcome is lacking. We investigated responsiveness to treatment, reproducibility, and minimal clinically important difference of the Patient Health Questionnaire-9 (PHQ-9), a standard instrument for diagnosing depression in primary care. This study included 434 intervention subjects from the IMPACT study, a multisite treatment trial of late-life depression (63% female, mean age 71 years). Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period. Test-retest reliability and minimal clinically important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart. The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months (-1.3 versus -0.9) and equivalent at 6 months (-1.3 versus -1.2). With respect to structured diagnostic interviews, both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression, partial remission, and full remission. Test-retest reliability of the PHQ-9 was excellent, and its minimal clinically important difference for individual change, estimated as 2 standard errors of measurement, was 5 points on the 0 to 27 point PHQ-9 scale. Well-validated as a diagnostic measure, the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes. Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research.
          Article 0 comments Cited 419 times – based on 0 reviews     Review now
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            Validity of the Brief Patient Health Questionnaire Mood Scale (PHQ-9) in the general population.

            Alexandra M. Martin, Winfried Rief, Antje Klaiberg … (2005)
            The aim of this study was to assess the validity of the Patient Health Questionnaire depression module (PHQ-9). It has been subject to studies in medical settings, but its validity as a screening for depression in the general population is unknown. A representative population sample (2,066 subjects, 14-93 years) filled in the PHQ-9 for diagnosis [major depressive disorder, other depressive disorder, depression screen-positive (DS+) and depression screen-negative (DS-)] and other measures for distress (GHQ-12), depression (Brief-BDI) and subjective health perception (EuroQOL; SF-36). A prevalence rate of 9.2% of a current PHQ depressive disorder (major depression 3.8%, subthreshold other depressive disorder 5.4%) was identified. The two depression groups had higher Brief-BDI and GHQ-12 scores, and reported lower health status (EuroQOL) and health-related quality of life (SF-36) than did the DS- group (P's < .001). Strong associations between PHQ-9 depression severity and convergent variables were found (with BDI r = .73, with GHQ-12 r = .59). The results support the construct validity of the PHQ depression scale, which seems to be a useful tool to recognize not only major depression but also subthreshold depressive disorder in the general population.
            Article 0 comments Cited 389 times – based on 0 reviews     Review now
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              The World Mental Health (WMH) Survey Initiative Version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI).

              R Kessler, T Ustün (2003)
              This paper presents an overview of the World Mental Health (WMH) Survey Initiative version of the World Health Organization (WHO) Composite International Diagnostic Interview (CIDI) and a discussion of the methodological research on which the development of the instrument was based. The WMH-CIDI includes a screening module and 40 sections that focus on diagnoses (22 sections), functioning (four sections), treatment (two sections), risk factors (four sections), socio-demographic correlates (seven sections), and methodological factors (two sections). Innovations compared to earlier versions of the CIDI include expansion of the diagnostic sections, a focus on 12-month as well as lifetime disorders in the same interview, detailed assessment of clinical severity, and inclusion of information on treatment, risk factors, and consequences. A computer-assisted version of the interview is available along with a direct data entry software system that can be used to keypunch responses to the paper-and-pencil version of the interview. Computer programs that generate diagnoses are also available based on both ICD-10 and DSM-IV criteria. Elaborate CD-ROM-based training materials are available to teach interviewers how to administer the interview as well as to teach supervisors how to monitor the quality of data collection.
              Article 0 comments Cited 228 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Jacqui McCoy:
                ORCID: https://orcid.org/0000-0002-1254-9610
                University of TasmaniaChurchill AvenueHobart, Australia61 03 6226 224061 03 6226 2240jsmccoy@utas.edu.au
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: March 2020
                Publication date (Electronic): 13 March 2020
                Volume: 9
                Issue: 3
                Electronic Location Identifier: e15540
                Affiliations
                [1 ] University of Tasmania Hobart Australia
                [2 ] Monash University Melbourne Australia
                Author notes
                Corresponding Author: Jacqui McCoy jsmccoy@ 123456utas.edu.au
                Author information
                https://orcid.org/0000-0002-1254-9610
                https://orcid.org/0000-0001-5341-1055
                https://orcid.org/0000-0001-6673-833X
                Article
                Publisher ID: v9i3e15540
                DOI: 10.2196/15540
                PMC ID: 7101496
                PubMed ID: 32167481
                SO-VID: b824c87b-8548-4e48-8374-de22edfcaf29
                Copyright © ©Jacqui McCoy, Suzanne Nielsen, Raimondo Bruno. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.03.2020.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 18 July 2019
                Date revision requested : 3 October 2019
                Date revision received : 17 October 2019
                Date accepted : 20 October 2019
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: codeine,opioids,dependence,rescheduling,drug policy
                Data availability:
                Keywords: codeine, opioids, dependence, rescheduling, drug policy

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