Managing inappropriate use of non-prescription combination analgesics containing codeine: A modified Delphi study

Accepted Manuscript Managing inappropriate use of non-prescription combination analgesics containing codeine: A modified Delphi study Amanda K. Gibbins, Penelope J. Wood, M Joy Spark PII:

S1551-7411(16)00062-0

DOI:

10.1016/j.sapharm.2016.02.015

Reference:

RSAP 722

To appear in:

Research in Social & Administrative Pharmacy

Received Date: 11 November 2015 Revised Date:

29 February 2016

Accepted Date: 29 February 2016

Please cite this article as: Gibbins AK, Wood PJ, Spark MJ, Managing inappropriate use of nonprescription combination analgesics containing codeine: A modified Delphi study, Research in Social & Administrative Pharmacy (2016), doi: 10.1016/j.sapharm.2016.02.015. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Title:

Managing inappropriate use of non-prescription combination analgesics

Authors: Amanda K Gibbins1, Penelope J Wood1, M Joy Spark1

School of Pharmacy and Applied Science, La Trobe Institute for Molecular Science, La Trobe

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containing codeine: A modified Delphi study

Corresponding Author: M. Joy Spark

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University, P.O. Box 199, Bendigo, Victoria 3552, Australia

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School of Pharmacy and Applied Science, La Trobe Institute for Molecular Science, La Trobe University, P.O. Box 199, Bendigo, Victoria 3552, Australia Telephone: 613 5444 7551

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Fax: 613 544 7878

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Email: [email protected]

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ABSTRACT

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Background: Misuse and/or dependence upon non-prescription combination analgesics

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containing codeine (NP-CACC) can result in serious physiological and psychological harms.

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Objective: To explore pharmacists’ and other healthcare professionals’ ideas and views

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on strategies for managing NP-CACC misuse and/or dependence in a community

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pharmacy setting.

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Methods: A 3-iteration modified Delphi study was conducted to gain the consensus view

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of panelists. Forty experts within the fields of pharmacy and drug misuse and/or

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dependence agreed to be on the panel. Questionnaires explored opinions on issues and

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possible strategies that could be used to manage NP-CACC misuse and/or dependence.

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Responses from the first-round questionnaire were summarised and reported back to

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panelists through the second-round questionnaire for further reflection and evaluation

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using a 6-point, Likert-type scale. Strategies included in the third-round questionnaire had

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agreement by more than 80% of panelists. Panelists provided feedback on effectiveness

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using a 6-point, Likert-type scale for impact.

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Results: The response rates for the 3 rounds were 65%, 67.5% and 55%, respectively.

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Panelists provided 54 strategies in round 1. In round 2 there was consensus agreement

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with 31 of these strategies. In round 3 there was consensus that 21 strategies were

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expected to be effective (>80% of panelists expected the strategy to be effective, median

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above Somewhat Effective (4), IQD ≤1). Of these, 8 were expected to have the most

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impact if implemented into clinical practice (chosen by 5 or more panelists in their Top 5

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for impact). The strategies identified as effective and likely to have the most impact on

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NP-CACC misuse/dependence in a community pharmacy setting were: utilisation of a

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national real-time database to monitor product sales to aid identification of at-risk people

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(100% effectiveness, rank 1 for impact); development of a referral pathway for

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management of people whom pharmacists have identified as at-risk(95.2% effectiveness,

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rank 2 for impact), and training to improve pharmacist communication with people (95%

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effectiveness, rank 2 for impact).

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Conclusions: The high level of consensus achieved indicates that the strategies generated

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represent useful approaches which could be utilised to manage NP-CACC misuse and/or

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dependence within community pharmacy in the future.

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KEY WORDS:

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Codeine containing analgesic; Community pharmacists; Delphi study; Pharmacy practice

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35 INTRODUCTION

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Combination analgesics containing codeine (CACC) are indicated in the treatment of mild

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to moderate pain as alternatives to single ingredient non-opioid analgesics. In a number

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of countries, including Australia and New Zealand, these products are available without

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prescription when they contain 8 mg to 15 mg of codeine phosphate, which is an opioid

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analgesic, in combination with a non-opioid analgesic (paracetamol/acetaminophen,

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ibuprofen or aspirin).1 In Australia these products are stored behind the counter where

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consumers are unable to self-select and a pharmacist is legally required to determine

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therapeutic need prior to any sale. Non-prescription CACC (NP-CACC) are safe for the

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majority of people for short-term use (3-5 days). Longer-term use requires referral for

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further investigation and alternative treatment.2 The codeine contained in NP-CACC

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exposes them to use for purposes other than indicated, such as self-medicating for

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mental health conditions, recreational purposes (misuse) and physical or psychological

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dependence.3,4 Overuse is an increasing concern for pharmacists, other health

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professionals and the Australian government because of the morbidity and toxicity

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associated with codeine misuse and dependence. The overall rate of codeine-associated

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deaths more than doubled from 3.5 per million in 2000, to 8.7 per million in 2009,

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although only 7.8% of the deaths were attributed to codeine toxicity alone.5 The increase

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in reports of codeine-related toxicity and morbidity has led to a call by some medical and

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government groups to have non-prescription codeine products made available via

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prescription only.6

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Misuse of NP-CACC obtained from community pharmacies in Australia and the United

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Kingdom (UK) is thought to be common. Pharmacists have reported suspicion of misuse

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and/or dependence of CACC sold within their pharmacy.7-10 The risks associated with

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codeine misuse include respiratory depression, cardiac arrest, medication-overuse

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headache and withdrawal symptoms. Dependence on the codeine component of CACCs

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can lead to their increased consumption, which may consequently lead to adverse effects

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associated with high doses of the accompanying non-opioid analgesic

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(paracetamol/acetaminophen, ibuprofen or aspirin).11 Supra-therapeutic doses of

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paracetamol/acetaminophen are known to lead to hepatotoxicity, whilst sustained

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consumption of large quantities of ibuprofen and/or aspirin may induce hypokalaemia,

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renal tubular acidosis and gastric ulceration.11-13 Concerns about inappropriate use of NP-

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CACC products has led to calls for changes to Australian legislation; consequently on May

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1st 2010, these medications were up-scheduled, which resulted in all NP-CACC being

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moved from where consumers could self-select to being kept behind the counter, and a

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pharmacist being required to determine therapeutic need for every sale. Recently it has

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been recommended that all Australian products containing codeine be rescheduled so

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they can only be obtained with a prescription from a doctor.6 This was to be implemented

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on June 1st 2016 but, following submissions from pharmacy groups, the pharmaceutical

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industry and key consumer groups, a final decision was deferred until June 2016.14

77 Following up-scheduling of NP-CACC in 2010, Australian pharmacists were required to

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establish therapeutic need, which prompted increased monitoring of NP-CACC purchases

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by pharmacists and an increased awareness of people who may not be using the product

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as prescribed.8 Prior to this, pharmacist management of inappropriate use of NP-CACC

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had been reported as needing improvement, particularly with regard to: identification of

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an issue, communication with the patient, referral and treatment.15 Identification of

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people misusing and/or dependent upon NP-CACC can be difficult for pharmacists, partly

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due to the ability for people to shop around pharmacies, and no mechanism to record NP-

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CACC sales across multiple pharmacies.7,8 Furthermore, pharmacists experience difficulty

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communicating product risks or addressing suspected dependence with people, possibly

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due to concerns about aggressive behavior if misuse and/or dependence is raised.15

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Additionally, it has been identified both in Australia and abroad that once a pharmacist

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has recognized that there is an issue, they are unsure of the best treatment strategies for

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these people or the appropriate referral pathways.7,15,16

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Misuse of NP medications appears to also be a concern for pharmacists in the UK.

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Intervention strategies used or seen as desirable by UK pharmacists to manage NP

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medication misuse include: suggesting patients seek the advice of GPs, better

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communication between primary health care professionals, sharing information amongst

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pharmacies, access to up-to-date local and national information about non-prescription

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drug misuse and developing an ‘early warning system’.10,17 While restricting access to

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medications that were being misused was reported as an important first step, support or 4

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counselling were considered likely to be more beneficial for more chronic cases of misuse.

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Training involving dealing with the problem of non-prescription medication misuse and

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other sensitive issues coupled with support from training organizations has been

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identified as a means of reducing inappropriate non-prescription medication sales in

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pharmacies.10,17 A community pharmacy harm minimization model has been trialed in

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Ireland for abuse or misuse of a small range of NP medicines [opioid (predominantly

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kaolin and morphine mixture), antihistamine or laxative].18,19 Pharmacists were asked to

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identify and recruit people they thought were misusing or abusing NP medicines. Then,

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depending on the medication involved, offer treatment or refer the person. Pharmacists

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raised the topic of inappropriate use with less than half (46%) of the people they

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identified as abusing or misusing one of the study medicines. Of the patients with whom

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pharmacists spoke, only 20% agreed to stop using the product and/or use a safer

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alternative; none of these patients completed the outcome component of the study.18

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These UK studies have focused on NP medicines as a group and some of the strategies

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used could be applicable to NP-CACC.

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Australian pharmacists have made suggestions for the appropriate management of NP-

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CACC requests. Suggestions include a real-time monitoring system, further pharmacist

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training in communication skills, greater collaboration with doctors and the development

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of effective programs to refer over-the-counter (OTC) CACC-dependent people for

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assistance, including pharmacy based programs.8,20 These are similar to the strategies

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identified for misuse of OTC medications in general in the UK, where there was also a call

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for greater consistency in the management of OTC misuse and the need for the

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development of nationally recognized guidelines for pharmacists.10,17 Previous studies

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gathered information from individuals but there is a need to explore wider views and

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reach agreement on the way forward for the management of misuse and/or dependence

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on codeine. This study aimed to explore and obtain consensus on potential specific

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strategies for managing NP-CACC misuse and/or dependence that would be expected to

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be effective and have impact if they were implemented in an Australian community

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pharmacy setting.

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130 METHODS

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A 3-iteration modified Delphi survey was chosen to explore potential strategies for the

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management of NP-CACC misuse and/or dependence in a community pharmacy setting.

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The Delphi survey technique is an anonymous structured group communication process;

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it involves a ‘panel of informed individuals’, or experts, undertaking a multi-faceted

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exploration of the topic of interest and establishing consensus opinion.21 The first-round

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questionnaire usually consists of open-ended questions to canvass opinions on a

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particular topic. Subsequent questionnaires are then built upon responses to the previous

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questionnaire. Group responses are summarised and returned to panelists who may

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modify their contribution in light of newly-shared opinions.22 This anonymous process

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enables the generation of a diverse and comprehensive range of opinions, whilst avoiding

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domination by individuals who may sway the responses of others. The process usually

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concludes when stability of opinion (consensus) is reached. However, in modified Delphi-

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surveys a pre-determined number of ‘rounds’ is used, which has been shown to be an

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effective and feasible means of gathering data in a timely and efficient manner.23 Pilot

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testing of questionnaires with a small group of individuals prior to release has been

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recommended.22,24

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Purposive sampling was used. A panel size of 40 was chosen to ensure at least 20

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responses each round with a minimum response rate of 50%. Delphi panel members with

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knowledge or understanding of NP-CACC medication misuse and/or dependence were

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recruited, by email or telephone, from a variety of health professions practicing in rural,

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regional, and metropolitan areas. The panel consisted of community pharmacists,

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clinicians managing OTC drug misuse and/or dependence, researchers, community health

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workers, pharmacy organisations and statutory bodies, and other relevant sectors (such

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as pharmaceutical industry employees). This heterogeneous sample could be expected to

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have a wide range of opinions.22

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A pilot test, using a cognitive interview process, was conducted for every round to assess

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question readability and interpretation, and thereby improve the quality of the data.25

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Between 2 and 4 local panelists (both pharmacist and non-pharmacist) were invited to

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participate in cognitive interviews. During the cognitive interviews the questionnaire was

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completed in front of a researcher, which allowed for comprehensive exploration of the

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participant experience of responding to the questions, and provided insight regarding

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patterns of interpretation of the questionnaire. After each cognitive interview the

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questionnaire was reviewed and amended, and then used in subsequent interviews. Once

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successive cognitive interviews indicated that no adjustments to the questionnaire were

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required, the questionnaire was finalized and released.

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Panelists had a choice of completing the questionnaires in either print or electronic form

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(via an emailed link to the questionnaire in Qualtrics). To protect anonymity all

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questionnaires were returned anonymously. Email reminders were sent to all panelists

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one week after distribution and the survey round was closed 3 weeks after distribution. 7

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No incentives were provided to panelists for completion of the questionnaires. Data were

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entered into Microsoft Word and Excel for analysis.

176 Delphi surveys have used a range of different strategies as markers of consensus.23,26-28

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Strategies used for this study were a median greater than the 4th point on a 6-point,

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Likert-type scale, a maximum interquartile deviation (IQD, interquartile range/2) of 1,26,27

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and 80% or more panelists selecting agreement/effectiveness (highest 3 groups on the

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Likert-type scale).23,28

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The first-round questionnaire (QR1) consisted of open-ended questions (Appendix A).

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These questions were written to allow panellists the freedom to generate statements or

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strategies relating to the topic.22 Cognitive interviews confirmed that the questions

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encouraged panelists to explore the topic. The initial two questions asked panelists to

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think about the current situation regarding CACC misuse and/or dependence and the

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current role of pharmacy in assisting and treating affected people. Strategies or ideas for

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assisting and treating CACC misuse and/or dependence were provided in response to

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questions 3 to 6. Responses to questions were grouped with similar

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suggestions/strategies using content analysis.24 Original participant wording, with the

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exception of minor editing, was retained for all suggestions. When multiple wordings

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were used, for what appeared to be the same suggestion/strategy, the authors

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condensed wordings to form one description for the particular strategy. All listed

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strategies were included in the second-round questionnaire.24 Consequently, panelists

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were responsible for evaluating all the suggested strategies for quality and effectiveness,

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rather than the authors.

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The items generated from QR1 were grouped into themes and returned to panelists in

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the second-round questionnaire (QR2). Panelists were asked to indicate their level of

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agreement with each item on a Likert-type scale from 1 (Strongly Disagree) to 6 (Strongly

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Agree). A 6-point scale was used to avoid a midpoint because of the reported unreliability

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of midpoints.29 Panelists were also given the opportunity to provide additional comments

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on suggestions/strategies if they wished.

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QR2 statements/strategies were ranked by median and percentage of respondents who

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agreed with the statement (Slightly Agree, Agree or Strongly Agree). Strategies with a

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median higher than Slightly Agree, IQD ≤1 and agreement from more than 80% of

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panelists were included in the third-round questionnaire (QR3) in a random order.

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Feedback from QR2 was provided to panelists in QR3 by including percentage of Agree

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and Strongly Agree responses for each statement. In QR3, the panelists were asked to

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rank how effective each strategy would be ‘in assisting pharmacies to manage CACC

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misuse/dependence and minimise harms associated with CACC overuse’ using a 6-point,

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Likert-type (1- Very Ineffective to 6- Very Effective). Panelists were then asked to consider

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the impact that individual strategies would have should they be implemented into clinical

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practice and rank the top 5 strategies they believed would ‘have the most impact on

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assisting pharmacies to manage CACC misuse/dependence and minimise harms

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associated with CACC overuse’. Once ranked, panelists were asked to comment briefly on

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the possible ‘opportunities’ and ‘pitfalls’ of implementing their 5 chosen strategies.

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QR3 strategies were ranked in 2 ways: 1) by median and percentage of respondents who

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thought the strategy would be effective, and 2) by the number of times the strategy was

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ranked in the top 5 for impact on clinical practice. The number of times a strategy would 9

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be selected if strategies were evenly distributed was calculated and strategies that

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received more than this number were considered to have consensus for impact in clinical

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practice.

227 Ethics approval for this study was obtained from the Faculty of Science, Technology and

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Engineering Human Ethics Committee, La Trobe University, Bendigo, Victoria, Australia

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FHEC14/R13.

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231 RESULTS

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Of the 52 health professionals with an interest in addiction medicine who were

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approached about participation in this study, 40 agreed to be on the panel. Of these, 70%

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were practicing within Victoria; others were recruited from South Australia, NSW and

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Queensland. Demographics for the original sample, and for the respondents to each

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survey round, are shown in Table 1.

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Analysis of QR1

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Of the 40 questionnaires sent out, 26 were returned (65%). Responses to the first 2

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questions indicated that at present misuse and dependence upon CACC is poorly and

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haphazardly identified. The 11 common responses to these questions were included in

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QR2. Responses to questions 3 to 6 produced 54 unique strategies for assisting and

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treating CACC misuse and/or dependence. The strategies were grouped into 6 themes for

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inclusion in QR2 (Table 2).

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Analysis of QR2

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Completed second-round questionnaires were received from 27 of the 40 panelists

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(67.5%). The median, IQR, IQD, and % agreement for each of the statements can be found 10

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in Table 2. More than 80% of panelists agreed with 32 statements; of these 31 had a

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median greater than Slightly Agree, 25 had an IQD of 0.5 and none of these statements

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had an IQD over 1. Accordingly, a good level of consensus was obtained from the panel.

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Strategies relating to reduced availability of NP-CACC (such as moving all CACC products

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to prescription only) and managing misuse and/or dependence solely within the

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pharmacy did not rank as highly as strategies related to increasing consumer education

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on risks/harms and improving referral opportunities (Table 2).

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Analysis of QR3

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Just over half of the third-round questionnaires (22/40) were returned to the research

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team; 20 were fully completed and 2 partially completed (with effectiveness ranked but

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not impact) and all were included in the data analysis. The median for perceived

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effectiveness, IQR, IQD, % perceived effectiveness and number of times chosen in the top

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5 for impact for each of the statements included in QR3 can be found in Table 2. There

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was consensus amongst panelists that 21 of the 31 strategies would be effective (median

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above Somewhat Effective and expected to be effective by more than 80% of panelists

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with an IQD of 1 or less) in assisting pharmacists to manage CACC misuse and/or

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dependence and minimise harms associated with CACC overuse. Up to 4 selections in the

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Top 5 would be expected from an even distribution. Nine of the 31 strategies were

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selected by 5 or more panelists in their Top 5 strategies for impact following

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implementation in clinical practice. Over 80% of panelists thought each of the nine Top 5

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strategies would be effective, and all except one had a median for perceived effectiveness

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of more than Somewhat Effective. One strategy about referral was considered effective

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by all panelists but was not considered to have the most impact compared to the other

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strategies. Comments relating to Top 5 impact strategy opportunities and pitfalls were

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analysed thematically (Table 3). Moderate variation was seen in those strategies ranked 11

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as ‘most effective’ and strategies ranked in the Top 5 for impact in clinical practice,

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indicating that not all effective strategies were considered to have a high impact in the

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current pharmacy practice setting.

277 Introduction of a real-time national monitoring database to identify those who may be

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misusing and/or dependent upon NP-CACC was listed as both the most effective strategy,

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and most likely to have an impact on clinical practice. Panelists indicated that, whilst this

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would be an efficient means of identifying those misusing and/or dependent upon NP-

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CACC, other strategies would be required to manage these people appropriately both

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within the pharmacy and in the wider health care setting. Implementation of a well-

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defined referral pathway and increasing the ability of pharmacists to interact with

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consumers in a more confident and informed manner were indicated as being able to

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improve the quality of pharmacist interventions.

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DISCUSSION

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The panel for this study generated a high degree of consensus on strategies that could be

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utilised by Australian pharmacies to manage CACC misuse and/or dependence and

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minimise harm associated with CACC overuse. These included: a tool to identify people

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potentially misusing or dependent on NP-CACC, a referral pathway, and training to

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improve communication with purchasers about the issue of potential dependence. These

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strategies are all within pharmacists’ current scope of practice in Australia.30 Most

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research has focused on the management of requests for NP-CACC rather than the

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management of people who may be misusing and/or dependent on these medications in

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the pharmacy setting.8,20,31 The 4 broad areas of identification, communication, referral

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and treatment have been reported as those in which pharmacists could improve their

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management of inappropriate use of NP-CACC.15,18 This study provides additional insight

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by identifying management strategies that could be implemented in a pharmacy setting.

301 Panelists indicated that NP-CACC misuse and/or dependence was currently poorly and

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haphazardly identified within the pharmacy. The independence of individual pharmacies

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limits a pharmacist’s ability to obtain full purchase histories of people, which has been

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reported to contribute to difficulties in identification of OTC drug misuse.7,8,15 The

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panelists supported implementation of a real-time national monitoring database to

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record and track sales of NP-CACC across multiple pharmacies; consequently breaking

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down each pharmacy’s isolation. The Australian Government has announced the

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intention to implement a national real-time reporting system for prescription opioids,

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which could potentially be utilised for NP-CACC in the future. Additionally, in response to

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the recent debate over whether NP-CACC should be made prescription only, the

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Australian Pharmacy Guild has been working on a “real-time monitoring and clinical

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decision support tool” to aid pharmacists in the decision of whether a NP-CACC is

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appropriate for a particular patient.32

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Despite the strong support, concerns were raised by panelists that a real-time national

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monitoring database may give apparent criminalisation to appropriate use of NP-CACC.

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This would be especially true if the current database for recording pseudoephedrine

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(Project STOP33), to which police have access, was used. A real-time monitoring system

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would play an important part in the identification component of managing people with

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NP-CACC misuse and/or dependence, but it would not address the problem of what to do

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for these people once an issue has been identified. The easiest response of refusing the

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sale does not address the persons health needs. In this way, codeine is very different to

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pseudoephedrine, which is diverted for use in methamphetamine manufacture, and

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refusing the sale does not result in direct detrimental patient outcomes.33

326 Once people who are possibly misusing and/or dependent upon CACC are identified,

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pharmacists report difficulty in instigating appropriate conversations about their NP-CACC

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use.8,17 Up-skilling pharmacists in ways to raise the issue of dependence with people and

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improving their communication were high priorities for panelists in this study. Altering

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the focus of pharmacist communication to encourage people to seek assistance and

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treatment from other services would encourage a different approach to the current

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“policing approach” utilised by many pharmacists. Pharmacists’ communication skills

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could be improved through training in the brief form of motivational interviewing which

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was developed for short consultations in the medical field.34 Conducting training through

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a series of short (2-3 hour) sessions spread over a number of weeks is likely to be more

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beneficial than a single intensive training session.18,19,34

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Increasing pharmacists’ ability to counsel individuals on evidenced-based pain

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management (such as paracetamol/acetaminophen, ibuprofen, and non-pharmacological

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methods) could also be an effective means of preventing misuse and/or dependence on

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NP-CACC. It has also been proposed that patient education at the point of purchase of

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non-prescription codeine would reduce the harms associated with the problematic

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patterns of use, but the efficacy of this strategy has yet to be studied.5 Dependence on

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NP-CACC often develops after prolonged use at recommended dosages.16 Therefore

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transitioning people to more appropriate treatment following appropriate short-term use

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could potentially reduce the rate of inadvertent dependence developing.

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The development and implementation of a well-defined referral pathway was identified

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in this study as another option to aid management. This would be a means of addressing

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pharmacists’ uncertainty of where to refer those who may be misusing and/or dependent

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upon NP-CACC.8 Panelists indicated that health professionals were often unsure how to

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best address codeine addiction. Referral pathways have been demonstrated to be an

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effective means of improving health care, and reducing time delays in provision of

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appropriate treatments.35,36 HealthPathways, a localised combined clinical tool and

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referral pathway37, has been found to promote integration of health care delivery with

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improve all aspects of the referral process.36

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Treatment strategies were not prioritised by panelists in this study as a role for

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pharmacists, despite treatment being identified as an area that could be improved by

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previous research.15 Additionally panelists did not think that restricting the availability of

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CACC would aid management, a strategy that the Australian Therapeutic Goods

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Administration is currently proposing.14

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A strength of this Delphi study is the consensus of a range of health professionals with

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experience in addiction medicine on strategies to improve the management of NP-CACC

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in Australia. Due to the lack of generalizability of the Delphi survey technique, results of

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this study might be influenced and/or limited by those panelists who chose to participate

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and results of this study may not be able to be generalized to pharmacies outside of

370

Australia. Despite this, strategies identified by this study should be explored further by

371

pilot testing new models for the community pharmacy setting. Studies assessing

372

implementation of these strategies would need to measure the incidence of drug

373

dependence and the economic impact for both users and society.

AC C

365

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374 CONCLUSION

376

A variety of strategies with the potential to address 3 of 4 previously identified gaps in the

377

management of NP-CACC misuse and/or dependence within community pharmacy were

378

identified by the panel. These included: identification (utilising a real-time national

379

monitoring database to monitor product sales ), communication (additional intensive

380

training to improve pharmacist communication with people around dependence issues

381

and pain management), and referral (development of a well-defined referral pathway

382

pharmacists can use when they identify people to be at-risk ). If implemented, these

383

strategies could provide pharmacists with the tools to identify people who may be

384

misusing and/or dependent on NP-CACC, give pharmacists the ability to raise the

385

possibility of misuse or dependence with a person and then refer them to the most

386

appropriate place for treatment. This would result in an improved person-centred care

387

approach for these at-risk people and reduce the incidence of long term misuse and/or

388

dependence.

SC

M AN U

TE D

EP

389

RI PT

375

ACKNOWLEDGEMENTS

391

The authors would like to acknowledge Diana Guzys for her assistance and support

392

throughout this study. The authors would also like to express gratitude for the invaluable

393

contribution of all the panelists who participated in the study. There were no external

394

sources of funding for this study.

AC C

390

395 396 397

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399

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400

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402

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13. Lewis JD, Kimmel SE, Localio AR et al. Risk of Serious Upper Gastrointestinal Toxicity With

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465

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466

26. Raskin MS The delphi study in field instruction revisited: Expert consensus on issues and

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33. The Pharmacy Guild of Australia 2007, Project Stop. The Pharmacy Guild of Australia. Available

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484

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485

35. Cheah J Clinical pathways – an evaluation of its impact on the quality of care in an acute care

486

general hospital in Singapore. Singapore Med J. 2000;41:335-346.

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36. McGeoch G, McGeoch P, Shand B Is HealthPathways effective? An online survey of hospital

488

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489

37. HealthPathways Barwon - Fact sheet. 2013, Barwon Health. Available at:

490

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491

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493

Appendix A

494

Open-ended questions in the first-round questionnaire (QR1)

496 497 498

1. How is CACC (combination analgesics containing codeine) misuse/dependence currently identified in the community? 2. What do you believe pharmacy’s current role is, in assisting and treating CACC

RI PT

495

misuse/dependence?

3. What strategies could be used to address some of the current issues/challenges

500

around assisting and treating people with codeine misuse/dependence (current

501

practice)?

SC

499

4. If the Government were to provide additional funding for a program to allow

503

pharmacists to be more hands-on in the management and treatment of CACC

504

misuse/dependence, what additional activities, roles or programs could

505

pharmacists take on – to improve management of CACC misuse/dependence?

506

5. In the absence of current legislation, what role do you believe pharmacy could

509

TE D

6. Do you have any other comments you would like to make?

EP

508

play in implementing harm minimisation strategies?

AC C

507

M AN U

502

21

510

ACCEPTED MANUSCRIPT

Table 1 Demographics for the panel and respondents for each survey round Frequency (%a) Variable

Agreed to QR1b

QR2c

QR3d

participate Sector 13 (33%)

10 (38%)

13 (48%)

8 (40%)

Clinicians

8 (20%)

6 (23%)

7 (26%)

4 (20%)

Pharmacy Regulation/

5 (13%)

2 (8%)

3 (11%)

2 (10%)

4 (10%)

2 (8%)

Community Health

SC

Legislation

4 (20%)

6 (23%)

3 (11%)

40

26 (65%)

27 (68%)

21 (53%)

15 (58%)

16 (59%)

11 (55%)

Total Responsese Gender

TE D

22 (55%)

Female

19 (48%)

11 (42%)

11 (41%)

9 (45%)

Metropolitan

19(48%)

13 (50%)

12 (44%)

9 (45%)

21 (53%)

13 (50%)

15 (56%)

11 (55%)

EP

Location

Rural/regional

AC C

Age (years)

2 (10%)

10 (25%)

Researchers and Industry

Male

1 (4%)

M AN U

Services Other - including

RI PT

Pharmacists

(n, Range, Mean ± SD)

n=26 31-73 years, 51.2 ± 12.8

511

a

% of the panel in each round

512

b

QR1 First-round questionnaire

513

c

QR2 Second-round questionnaire

514

d

QR3 Third-round questionnaire

515

e

% of all panel members responding to the round

n=26

n=18

28-72 years, 29-66 years 50.9 ± 13.3

47.7 ± 12.2

22

ACCEPTED MANUSCRIPT

impact from round 3

SlA-StA

1

96.3

CACC misuse/dependence is usually only identified once serious health problems occur

A

SlD-A

1

66.7

1.3 1.4

b

M AN U

TE D

EP

1.5

Research reports from clinicians, forensic investigators and other researchers examine the issue only from a population level.

SlA

D-A

1.5

55.6

Locum pharmacists are an efficient means of identifying dependence within the pharmacy

SlD

D-A

1.5

42.3

D

D-SlA

1

25.9

StA

A-StA

0.5

100.0

AC C

1.1

Families, friends, or individuals themselves report serious dependence to GP’s

d

d

Impact

A

% Effective [SoE-VE]

Customer appearance, repeated requests and intuition are used by pharmacists when deciding whether to supply

b

1.2

R3 IQD

100.0

a

0.5

R3 IQR Effectiveness

A-StA

R3 Median Effectiveness

a

% Agree [SlA-StA]

A

Section 1 - Current identification and management in the community

c

The general community has a poor understanding of the risks of CACC and believes that if something is readily available it is safe

Question

R2 IQR Agreement

1.6

SC

R2 IQD

a

R2 Median Agreement

QR2 question number

d

517

RI PT

Table 2: Statements and strategies provided by panelists in round 1 and their level of agreement from round 2, level of perceived effectiveness and

a

516

Section 2 - Pharmacy's current role in assisting and treating CACC misuse/dependence Pharmacists should use 'universal precautions' for all people requesting CACC including advising patients of risks and asking questions that may suggest whether a person is dependent 2.2

23

ACCEPTED MANUSCRIPT

Pharmacists should ensure those seeking non-prescription CACC have a legitimate therapeutic need

StA

A-StA

0.5

RI PT

2.1

96.3

Alternatives such as paracetamol or ibuprofen alone should be offered

A

A

0

96.3

2.4

Pharmacists should contact a person's GP (if known) if they suspect dependence upon CACC or provide contact details for counselling such as DirectLine

A

SlA-StA

1

92.6

2.3

Many pharmacists ignore the issue of dependence rather than confronting it because people become aggressive when they are refused the drugs.

A

SlA-A

0.5

88.9

3.4 3.3

M AN U

Section 3 - Related to restricting product availability Reduce unnecessary and large take-away packs of CACC prescribed upon hospital discharge

A

A-StA

0.5

92.6

E

E-VE

0.5

85.7

3

Restrict the maximum pack size to no more than 18 tablets (three days treatment)

A

A-StA

0.5

85.2

E

SoE-E

0.5

81.0

5

Limit the number of boxes of non-prescription CACC available per person as a schedule 3 product. After this limit has been reached these products could become prescription only

A

D-StA

2

70.4

SlA

SlD-StA

1.5

70.4

SlA

D-A

1.5

55.6

E

E-VE

0.5

100.0

12

3.8

Removing the words 'Plus' or 'Extra' from products

TE D

3.5 3.9

SC

2.5

Once CACC dependence has been identified restrict purchases to an agreed level with the individual Allow only certain pharmacies to sell non-prescription CACC, where pharmacists are trained to help and support people and refer people where required

D

StD-SlA

1.5

37.0

3.1

Reschedule all non-prescription CACC to Schedule 4 (prescription only)

D

StD-SlA

1.5

33.3

3.2

Delete non-prescription CACC products from registration (sale) in Australia

D

StD-SlA

1.5

29.6

3.7

Disallow sales of non-prescription CACC in pharmacies unwilling to provide subsidised dispensing of opioid replacement therapy (methadone, buprenorphine)

D

StD-SlA

1.5

25.9

A

A-StA

0.5

92.6

AC C

EP

3.6

Section 4 - Related to monitoring product usage 4.1

A compulsory and legislated real-time national monitoring database (similar to Project STOP)

24

ACCEPTED MANUSCRIPT

Developing and using scripted responses to requests for non-prescription products

A

SlA-StA

1

4.3

Consider making all S3 products recordable, and introduce better prescribing tools for them - e.g. a module on GuildCare, renal function testing etc.

A

SlA-A

0.5

77.8

A professional program like a 5CPA PPI where someone identified as regularly using CACC's would be enrolled as a "registered user" with a particular pharmacy. The Pharmacy would be funded to ensure supply is appropriate (quantity / frequency), and to liaise with the individual’s GP.

A

SlD-A

1

66.7

SlA

SlD-A

1

66.7

92.6

E

SoE-E

0.5

95.5

3

SC

RI PT

4.2

4.5

M AN U

A model similar to the 'asthma card' in NSW where purchases of non-prescription codeine are recorded on an individual’s CACC card including date of purchase, pharmacy purchased, quantity etc. 4.4 Section 5 - Related to patient education

Counselling on quality use of analgesics, including when to discontinue OTC CACC, and where to go for help

A

A-StA

0.5

100.0

E

SoE-E

0.5

90.9

2

5.6

New (and larger) cautionary and advisory labels which warn of the dangers of too much ibuprofen, and/or of too much paracetamol

A

A-StA

0.5

96.3

SoE-E

SoE-E

0.5

95.5

6

Counselling individuals about evidenced-based treatment for pain (back pain, headache) such as paracetamol, ibuprofen, and non-pharmacological methods of pain management

A

A-StA

0.5

96.3

E

SoE-E

0.5

100.0

3

TE D

5.3

EP

5.9

Provide product inserts (not-CMI) on product risks and/or information pamphlets

A

SlA-A

0.5

96.3

SoE

SoIn-E

0.5

71.4

2

5.1

Telling all people about the risks of codeine (including addiction), and risks of higher than recommended doses of the non-opioid analgesics in the combination products.

A

SlA-StA

1

96.3

E

SoE-E

0.5

90.9

1

Proper pharmacist consultations in a private area

A

A-StA

0.5

96.0

E

SoE-E

0.5

95.5

0

Provide a Leaflet with signs/symptoms of codeine addiction and if you are experiencing 3+ of these symptoms you may have a problem. Include contact details for assistance

A

A-StA

0.5

92.6

SoE

SoE-E

0.5

95.0

5

Public education so that people are aware of the legal requirements and that S3 products are not OTC but are "pharmacist prescribed"

A

A-StA

0.5

88.9

E

SoE-E

0.5

86.4

4

5.13

AC C

5.5

5.8 5.7

25

ACCEPTED MANUSCRIPT

5.12

Ensure those individuals who become dependent are given a comprehensive explanation of harm minimisation strategies, including opioid replacement therapy

A

5.10

Advertising alternatives to OTC CACC for pain management

A

SlA-A

Explain to people how to recognise symptoms of product toxicity including peptic ulcer pain, anaemia, hypokalaemia symptoms

A

SlA-StA

5.4

A well-funded national campaign similar to QUIT or the Grim Reaper (AIDs campaign), or TAC

Discuss with people that there is little analgesic advantage with the small dose of codeine in these OTC products. Section 6 - Related to increasing pharmacists scope

1

88.9

E

SoE-E

0.5

95.2

2

0.5

85.2

SoE

SoE-E

0.5

81.0

1

1

85.2

SoE

SoE-E

0.5

81.0

2

RI PT

SC

5.11

A

SlD-StA

1.5

70.4

SlA

SlA-StA

1

81.5

M AN U

5.2

SlA-StA

A

A-StA

0.5

100.0

E

E-VE

0.5

100.0

5

6.5

Better education for pharmacists to increase understanding of various types of pain and treatments and to understand addiction/mental health issues

A

A-StA

0.5

96.3

E

SoE-E

0.5

95.2

4

6.3

Have pharmacists work more closely with Alcohol and other Drug (AOD) agencies when dependence identified

A

SlA-StA

1

92.6

E

SoE-E

0.5

95.2

3

Up-skill pharmacists to manage those who are misusing/dependent on CACC more effectively. i.e. train pharmacists to communicate with them and engage in appropriate conversation to try and find a solution to their problem and move away from the current 'policing approach'

A

A-StA

0.5

88.9

E

SoE-VE

1

95.0

7

EP

TE D

Pharmacist training to increase confidence in raising the issue of dependence with individuals thought to be dependent on CACC

6.10

AC C

6.4 6.8

Pharmacist post-grad specialty in Drug addiction/dependence

A

SlA-A

0.5

88.9

SoE

SoIn-E

1

66.7

2

6.7

Pharmacist post-grad specialty in pain management

A

SlA-A

0.5

85.2

SoE

SoIn-E

1

66.7

0

Have centres where pharmacists could be more involved in guiding/supporting those dependent upon CACC with follow-ups and treatment plans

A

SlD-StA

1.5

74.1

6.11

26

ACCEPTED MANUSCRIPT

SlA

SlA-A

0.5

77.8

Changing legislation to afford pharmacists more authority to deal with non-prescription CACC misuse/dependence

SlA

SlD-A

1

66.7

SlA

D-SlA

1

59.3

SlA

D-A

1.5

55.6

SlD

D-A

1.5

48.1

6.12

6.6 6.9

Have a pharmacist-run non-prescription Codeine dependence/over-use clinic Financial incentives for pharmacists who identify those with a problem and encourage them to seek treatment.

M AN U

6.1

SC

6.2

RI PT

Have pharmacists follow-up those sold CACCs to see if pain control is adequate and that long-term use of CACC is not becoming a problem. Then refer individuals to GPs etc. for further investigations and treatments when CACCs are not giving adequate pain relief.

Allow pharmacists to prescribe appropriate treatment to patients in cases of OTC CACC dependence Have pharmacists teach the cold water extraction method to appropriate individuals

D

StD-SlA

1.5

25.9

6.14

Returning to the old practice where pharmacists could repeat a Doctor’s prescription at their own discretion

D

StD-SlD

1

22.2

TE D

6.13

Section 7 - Related to referral

Refer people to other health professionals such as GP's, dentists, or physiotherapists if pain remains despite CACC use

A

A-StA

0.5

100.0

E

E

7.3

Develop and implement a well-defined referral pathway to manage cases of OTC CACC dependence

A

A-StA

0.5

100.0

E

7.5

Providing people with contact details for agencies that can assist with dependence

A

A-StA

0.5

100.0

7.1

Report all suspected cases of misuse/dependence to individuals GP

A

SlA-StA

1

A

SlA-A

SlA

StA

7.4

AC C

7.6

EP

7.2

Ensure local magistrate courts are aware of appropriate referral and treatment services available Have a specific Codeine addiction centre to refer people similar to the methadone/addiction program

0

100.0

1

E-VE

0.5

95.2

7

E

SoE-E

0.5

95.2

5

85.2

E

SoE-E

0.5

95.2

6

0.5

84.6

SoE

SoE

0

85.7

0

D-A

1.5

59.3

A-StA

0.5

88.9

E

0

95.2

4

Section 8 - Related to providing treatment 8.1

Encourage more pharmacies to be involved in providing Opioid Substitution Therapy (OST)

E

27

8.6

8.4 8.3 8.7 8.5

A

96.3

SoE-E

Recommend monitoring of renal function/liver function as appropriate

A

SlA-A

0.5

96.3

SoE

SoE

Provide greater access to follow-up for those receiving Opioid Substitution treatment

A

SlA-A

0.5

92.6

SoE

A

SlA-A

0.5

88.9

SoE

SlA

SlD-A

1

66.7

Facilitate transfer to prescription only analgesics to avoid NSAID/paracetamol toxicity

SlA

SlD-A

1

70.4

Make free counselling services available within the pharmacy

SlD

D-A

1.5

48.1

Developing a brief intervention within the pharmacy to assist those dependent on CACC

Develop and implement a protocol for a managed withdrawal program within the pharmacy

518

A-StA

0.5

RI PT

8.8

Tailor Opioid Substitution Therapy (OST) to be more effective or appropriate for OTC opioid addiction

M AN U

8.2

SC

ACCEPTED MANUSCRIPT

a

StA - Strongly Agree A - Agree, SlA - Slightly Agree, SlD - Slightly Disagree, D - Disagree, StD - Strongly Disagree

520

b

IQR interquartile range

521

c

IQD interquartile deviation = IQR/2

522

d

VE - Very Effective, E - Effective, SoE - Somewhat Effective, SoIn - Somewhat Ineffective, In - Ineffective, VIn - Very Ineffective

523

e

Impact - Number of times selected by a panelist in their Top 5 for impact

0.5

81.8

2

0

81.0

1

SoE-E

0.5

95.2

4

SoE-E

0.5

90.5

1

AC C

EP

TE D

519

SoE-E

28

ACCEPTED MANUSCRIPT

practice with reported opportunities and pitfalls Strategy

Frequency in

Opportunities

Develop and implement a well-defined referral

7

M AN U

monitoring database (similar to Project STOP)

Invaluable resource which helps to identify patients who are using too much CACC. Can then restrict drug availability and manage

Whilst it may help identify patients, what do you

dependence.

do once you identify them? Still need strategies to

Similar handling of requites by pharmacists across Australia.

decline supply/help the patient.

Technology already exists but it needs to be used universally and be

Apparent criminalisation of appropriate NP-CACC

TE D

12

underpinned by regulation. As the consumption is not illegal, the

use. Nanny state? Privacy legislation required.

police should not be able to access the database

Pharmacists may rely solely on this system.

Critical to guide consumers once issues have been identified.

Funding would be required, and proper training is

EP

A compulsory and legislated real-time national

Will help integrate care and can lead to better coordination with

dependence

other health professionals.

misusing/dependent on CACC more effectively. i.e. train pharmacists to communicate with them and engage in appropriate conversation to try and find

AC C

pathway to manage cases of OTC CACC

Up-skill pharmacists to manage those who are

7

Pitfalls

SC

Top 5a

RI PT

Table 3 Third-round questionnaire (QR3) strategies selected by 5 or more panelists as expected to have the most impact if implemented into clinical

a must

This will improve community’s relationship with, and trust in,

Time consuming and funding required for

pharmacists along with improving pharmacists skills.

pharmacist to spend the necessary time with

Improved pain management with more holistic approach.

patients How will pharmacists be trained?

29

ACCEPTED MANUSCRIPT

Frequency in

Opportunities

Top 5a a solution to their problem and move away from

SC

the current ‘policing approach’ Highlight the risks. Information is power.

Some patients are aware and ignore the risks.

which warn of the dangers of too much ibuprofen

Better warnings for patients unaware of risks.

Has this strategy worked with tobacco?

and/or paracetamol

Will gives pharmacists the opportunity to intervene in a way which

Not a panacea, but useful

6

M AN U

New (and larger) cautionary and advisory labels

Pitfalls

RI PT

Strategy

uses "borrowed protection".

6

Restrict the maximum pack size to no more than 18

5

raising the issue of dependence with individuals thought to be dependent on CACC

treat / refer appropriately.

on the issue of OTC CCAC misuse/dependence.

Team approach to management; better outcome for the patient

GP’s time constraints and possible training needs.

Improve GP/Pharmacist relationship

Open to breach of confidentiality claims

Emphasis on more appropriate treatment time course.

Cost to the patient.

Less waste & should encourage people to see GP.

People can buy multiple packs at multiple

AC C

tablets (three days treatment)

Pharmacist training to increase confidence in

GP and pharmacist often have differing opinions

TE D

to individual’s GP.

GPs are well placed to take a holistic view of patients’ needs and

EP

Report all suspected cases of misuse/dependence

5

pharmacies each day

The ability to initiate potentially difficult clinical encounters is vital.

All pharmacists must comply

Increased pharmacist confidence will lessen patient aggression.

May risk targeting the wrong people or an

Pharmacists would be more likely to intervene.

aggressive response

30

ACCEPTED MANUSCRIPT

Frequency in

Opportunities

Top 5a 5

that can assist with dependence

help are big barriers to help-seeking.

may well not do that. Cost. Funding to produce the leaflet, brand-specific if

codeine addiction and if you are experiencing

Non-confrontational and can be considered in their own time.

sponsored by manufacturer.

3+ of these you may have a problem. Include

Better patient understanding of issue. Good way to start a

The uninitiated may be encouraged to try these

contact details for assistance

conversation

products.

M AN U

Allows patient to take control of themselves via leaflet.

5

Contact details must be easy for patient to access.

EP

Number of times the strategy was included among the Top 5 for impact if implemented into clinical practice.

AC C

a

Clients still need to actually call the service, and

TE D

Provide a leaflet with signs/symptoms of

Recognising that you have a problem and knowing where to seek

SC

Provide people with contact details for agencies

Pitfalls

RI PT

Strategy

31

ACCEPTED MANUSCRIPT

Synopsis This article describes a 3-iteration Delphi study used to explore the ideas and views of experts within the fields of pharmacy, and drug addiction/abuse on possible strategies for management of non-

RI PT

prescription combination analgesics containing codeine through community pharmacies. The key strategies to emerge from the study were utilisation of a national real-time database to monitor product sales to aid identification of at risk people; training to improve pharmacist communication

SC

with people; and development of a referral pathway for management of people pharmacists have

AC C

EP

TE D

M AN U

identified as at-risk.