Introduction
Opioid substitution therapy (OST) programs are successful at addressing dependence on heroin and other opioid substances [
1,
2]. These programs involve the assessment and treatment of people with an opioid addiction and the dispensing of OST medicines to address their dependence on heroin and/or other opioid substances. This, in turn, reduces the negative behaviours, health issues, physiological issues and crime associated with opioid misuse [
3,
4]. OST has been proven cost-effective [
2,
5,
6] for governments due to the reduction of illicit drug use costs to the health system [
1,
7,
8] and decreased crime rate and other indirect costs to society [
9,
10]. The primary aim of OST is for patients to decrease and eventually cease their opioid misuse and improve their quality of life [
11]. The positive outcomes observed from OST include decreased risk of injecting infections, illnesses and fatalities [
9,
12] and increased ability to perform daily tasks as compared to when using illicit heroin [
4].
There are three OST medicines available in Australia and all three should be administered at a pharmacy under a pharmacist’s supervision, unless take-away doses have been authorised. The most commonly used medicine is methadone which needs to be taken daily. Buprenorphine (branded as Subutex®) and buprenorphine with naloxone (branded as Suboxone®) have varied dosing requirements with frequency ranging between daily to every third day [
13]. All three OST medicines are subsidised by the Australian government through Section 100 of the National Health Act 1953 (Cth) and are included in the Pharmaceutical Benefits Scheme (PBS) [
14,
15]. However, the dispensing fees associated with supplying the medicines have to be paid by patients and do not contribute towards the Safety Net Scheme [
12,
16], which is a scheme that provides financial assistance to patients with substantial pharmaceutical expenses [
17]. There is no set dispensing fee charged to OST patients and there are large price disparities across community pharmacies in the various Australian jurisdictions [
12]. Previous research indicated that OST fees ranged between $18 and $56 per week [
18].
Various approaches need to be followed in the management of opioid addiction and there are many variables that may affect a patient’s success and retention on the OST program. Although financial support towards dispensing fees is only one aspect to encourage patients to be treated and be retained in care financial instability is one concern that is frequently raised [
10,
18,
19]. The demographic of patients on OST is generally in the lower income bracket and it was estimated in 2005 that only 17% of Australian OST patients received their main income from paid work [
20]. Income from government support has, however, been reported to be insufficient for patients to buy groceries with some patients having to prioritise their OST fees over buying food on certain occasions [
15]. It has also been found that large numbers of patients have acquired significant debt to pharmacies to cover the dispensing fees [
12,
21‐
24].
A 2008 Australian study involving 508 OST patients found that 23% of the patients owed money to pharmacies and 32% of the patients could not afford the dispensing fees, which resulted in some patients missing their dose(s) [
18]. This study also indicated that patients were not satisfied with the dosing hours, number of venues available to dose, and not having enough take-away doses [
18]. A study conducted in the United States of America (USA) evaluated the retention rates of patients on OST within two states after OST treatment subsidisation by Medicaid was introduced [
19]. The retention rates increased from 28% to 51% in one state and from 28% to 34% in the other, suggesting that financial aid can positively impact OST retention rates [
19]. Another USA study in which patients were provided with incentive vouchers in order to increase program adherence similarly showed increased retention rates [
25].
Although there has been some research into the factors influencing OST program retention rates there has been limited research covering OST patients’ finances and the potential impact of dispensing fees on compliance and retention in the OST program[
19,
26]. This study aimed to obtain opinions and feedback from patients and stakeholders about the impact of dispensing fees on patients’ debt, lifestyles and success or retention in the OST program.
Methods
This study was conducted in Perth, Western Australia, between June and August 2013. A mixed methodology involving quantitative and qualitative data collection strategies was used to obtain data from OST patients and stakeholders. Three approaches were utilised namely 1) interviews with OST stakeholders, 2) a focus group of OST patients and 3) surveys of OST patients. All information and data collected were de-identified and participants’ identities remained confidential. Ethics approval was obtained from the Curtin University Human Ethics Committee (approval number PH-10-13).
Stakeholder and focus group interviews
A stakeholder interview guide was developed to gather opinions and perspectives on how OST dispensing fees potentially impacted on patients and whether there could be a correlation between the fees and patient compliance and retention in the program. The interview guide consisted of 10 open-ended questions that covered:
-
Whether time on OST correlated with ongoing abstinence from opioids
-
OST patient financial aspects: groups of patients who struggle to pay dispensing fees (i.e. single mothers, teenagers), pricing of take-away doses, potential impact of dispensing fees on lifestyle factors, accumulated dispensing fee debt and the potential value of finance workshops to up-skill patients
-
Recommendations to improve or regulate the cost of OST dispensing fees.
Stakeholders were purposively selected to ensure participants were knowledgeable about OST medicine supply issues. All stakeholders approached were therefore in regular contact with OST patients and in an ideal position to provide feedback about the program. Potential stakeholder participants were given an information sheet about the study and asked to sign a consent form. Interviews were conducted face-to-face at a time and place that was convenient for the participants.
An open-ended focus group guide was developed to generate discussion with OST patients focusing on:
-
The impact of dispensing fees on lifestyle and retention and success with OST
-
Potential value of finance and lifestyle workshops to up-skill OST patients
-
Recommendations to improve or regulate the cost of OST dispensing fees
Focus group participants were purposively selected by the Western Australia Substance Users Association (WASUA) staff members to involve patients with varying opinions and experiences with the OST program. All participants were given an information sheet about the study and asked to sign a consent form. The focus group was conducted at the WASUA offices.
The interviews and focus group were conducted by members of the research team skilled in interview techniques and the running of a focus group. All stakeholder and focus group interviews were audio-recorded.
Surveys
A survey consisting of eleven questions was developed to collect some information about OST patients’ status (i.e. relationships, employment and children), duration of OST treatment, factors impacting on the success of treatment, current income level and whether dispensing fees altered their lifestyle or contributed to debt. The survey was designed as a two-page survey as consultation with health professionals involved with OST patients and WASUA staff indicated that the survey had to be short to facilitate participation. The surveys were distributed over a six week period through:
-
A specialist OST medical clinic located near the Perth central business district (CBD) that provided services to approximately 500 OST patients
-
WASUA, and
-
Two community pharmacies located north and south of the Perth CBD. These pharmacies were two of the largest OST dispensing pharmacies in Perth.
These locations were carefully selected to ensure a diverse range of OST patients were surveyed and to reduce any bias towards particular patient demographics. Staff at the various locations were briefed about the study and provided with background information and instructions about eligibility criteria, namely patients on OST at the time of the study who were ≥ 18 years old. The staff made the participant information sheets and surveys available to eligible patients during patient visits, indicating that participation in the survey was voluntary.
Data analyses
Qualitative analyses: All stakeholder and focus group interviews were manually transcribed. Participants were de-identified and codes were used in the analysis. Data analysis was informed by the general inductive approach [
27]: transcript content was read repeatedly by the research team to attain a thorough understanding of topics that emerged from the interviews. A colour-coding scheme was used to identify themes. Topics and themes were developed to capture core messages reported by the participants. Emerged ideas or themes were recorded and supporting quotes documented under each theme. To ensure reliability of the process of analysis all authors reviewed the themes and provided input throughout the data analysis process.
Quantitative analyses: The association between the two primary outcome variables (debt and impact on lifestyle) was assessed using the Chi-square statistic. Logistic regression models were used to identify independent variables which were associated with each of these outcomes. For each outcome, the independent variables included: cost 1) considered to cause a significant impact, 2) cost per fortnight (dispensing fee), and 3) demographic data: single, employed, having dependent children, and time on the OST program. The Likert scale responses (scores: 1 to 5) for the dependent variables were reduced by classifying responses 1,2 as ‘low impact’, and 4,5 as causing significant impact. The middle response indicating ‘sometimes impact’, was excluded from analysis. For each outcome, a ‘backwards elimination’ method was used to reach the optimum model. This method involves fitting all the independent variables to the model initially, then dropping the least significant variable (one at a time) until all variables remaining in the model were significantly associated with the outcome. Results of these regressions were presented as odds ratios, their 95% confidence intervals, and p-values. For all tests, a p-value < 0.05 was taken to indicate a statistically significant association. Analyses were performed using the SPSS version 21 statistical software.
Discussion
This study obtained opinions and feedback from patients and stakeholders about the impact of dispensing fees on patients’ debt, lifestyles and success or retention in the OST program. The stakeholders and OST patients both identified OST out-of-pocket dispensing fees as the main factor associated with OST non-compliance and early drop-out from the OST program. The survey data showed that dispensing fees impacted patients’ treatment in several ways including treatment compliance, debt accumulation and impact on lifestyle. All of these factors may increase the chance of a patient leaving the program. OST cost indeed received the highest rating in influencing retention in the OST program and there was a positive correlation between time on the OST program and success in terms of relapse prevention.
Treating a person with heroin or another opioid addiction is complex and the treatment process is multifaceted, requiring a holistic approach [
28]. Seeking abstinence may not be the immediate goal but rather seeking normality and stability in the patient’s life [
9,
12]. The length of time a patient spends on OST is positively correlated with therapy success [
19]. The first 12 months in OST is important as patients are at high risk of relapsing, are often financially unstable and vulnerable. It is therefore important to keep patients in the program during this initial stage. Retainment in the program in the initial phase of OST tends to increase the patient’s chance of obtaining long-term stability and abstinence from the addicted drug [
26]. Patients often need to work on repairing relationships, treating other health issues (HIV [
5,
8], malnutrition [
29], and mental health disorders [
30]), and gain financial stability via a regular income source [
22,
28,
31]. In order for patients to achieve these goals they require OST to treat the physical withdrawal symptoms caused by ceasing the use of the abused drug.
The findings from this study suggest that treatment is impacted negatively by out-of-pocket OST dispensing fees as patients often encounter financial pressures. As the study sample seems to be representative of the wider OST community in Western Australia [
20] the findings should be similar for other OST patients in this state. This study also highlighted a number of reasons why a patient may drop out of an OST program, with the main reason being the cost of the dispensing fee. Previous studies indicated that financial incentives and rewards increase patient compliance [
23,
25,
32]. This highlights the importance of financial assistance to improve patient retention rates in OST programs.
Survey data showed that OST patients’ lifestyles were impacted by the cost of the dispensing fees. Additionally, there was a correlation between participants who indicated that the fees impacted on their lifestyle and the accumulation of high personal debt. These findings show that the current charging practices of OST dispensing fees not only increase drop-out rates due to an increase in the relapse risk [
33‐
35] and the inability to pay for doses, but also increase the risk of adverse health problems. Financial pressure from personal debt has been linked to an increased risk of substance abuse [
36], mental health issues, depression, suicidal ideation, stress, and anxiety [
36‐
38]. The prevalence of these health issues are high in drug addiction patients [
39] and the added financial pressure from the dispensing fees are likely to exacerbate these conditions.
The World Health Organisation (WHO) states that healthcare systems should aim to provide equitable healthcare to all people. WHO defines health equity as “
the absence of unfair and avoidable or remediable differences in health services and outcomes among groups of people”[
40]. In 2000 WHO identified three areas of focus namely “
health, responsiveness and financing fairness” [
41]. Patients in OST programmes need to pay regular dispensing fees and they hence have extra health expenses. Although the PBS provides for the medicine itself to be entirely subsidised by the government, the fee associated with the dispensing of the medicine is not regulated and there is no financial assistance for this fee in Western Australia. Participants were of the opinion that OST dispensing fees should contribute towards the PBS Safety Net Scheme as is the case with patients who suffer from chronic conditions. Considering the current dispensing fees, Western Australian OST patients who obtain their OST medicines at community pharmacies pay on average $154 per month for their dosing, which is significantly more compared to patients paying for medicines for diabetes, smoking, and hypercholesterolemia. Although these conditions could also be the result of lifestyle choices, the dispensing of the medicines to treat these conditions contributes towards a patient’s Safety Net, which is not the case with OST medicines. Opioid dependence is therefore not considered at the same level as other medical conditions and OST patients are financially disadvantaged under the current PBS arrangements.
Interview participants indicated that patients are often in debt to pharmacies as a result of their inability to pay the dispensing fees. Pharmacy staff therefore need to follow-up with patients to recover the debt which adds to perceptions of stigma from staff as well as self-stigma by patients. It could be argued that pharmacists might be able to dose more patients and more pharmacies might be willing to participate in the OST program should the government sponsor the dispensing fees.
This study was limited by the small number of venues surveyed. In addition, the surveys relied on the accuracy of self-reported data. However, this method was deemed appropriate to obtain data from this vulnerable population. The study only involved OST patients within the Perth metropolitan area and therefore lacks country and rural patients’ perspectives. Furthermore, the study was conducted in Australia and the findings may not apply to settings outside Australia. Purposive sampling was used to locate key stakeholders, possibly limiting the generalisability of the interview findings. However, purposive sampling was deemed the most appropriate method of ensuring that stakeholders were familiar with the topic of discussion. The interview method can be subject to interview bias, and participants may lean towards responses which have greater social desirability. However, the potential for interviewer bias was minimised with the use of a standardised interview framework. Finally, this study was time-limited and conducted over a relatively short timeframe which reduced the scope of the study.
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Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
HLH was responsible for conceptualisation and coordination of the project. AS and BP developed the interview guides and survey questions and conducted the stakeholder interviews. All authors conducted the focus group. AS transcribed the interviews and did the initial thematic analysis. BP performed the initial statistical analysis. Data interpretation and analysis were confirmed by HLH. All authors read and approved the final manuscript.