Community Program for Opioid Pharmacotherapy 2012 Annual Report Pharmaceutical Services Branch Suggested citation Department of Health 2013, Western Australian Community Program for Opioid Pharmacotherapy 2012 Annual Report, Pharmaceutical Services Branch, Public Health and Clinical Services Division, Department of Health, Western Australia 1 Contents Contents ..................................................................................................................................... 2 List of figures ............................................................................................................................. 5 Executive summary ................................................................................................................... 6 Glossary of terms ...................................................................................................................... 7 Overview ..................................................................................................................................... 9 Introduction............................................................................................................................... 9 Opioid pharmacotherapy prescribing in WA ............................................................................. 9 Methodology ............................................................................................................................. 9 2012 results .............................................................................................................................. 11 Section one – authorisations issued ....................................................................................... 11 Number of authorisations issued ........................................................................................ 11 Authorisation type and opioid pharmacotherapy ................................................................. 12 Authorisations issued by gender ......................................................................................... 12 Authorisations issued by Area Health Service .................................................................... 13 Termination of authorisations.............................................................................................. 14 Patients dosing by opioid pharmacotherapy ....................................................................... 15 Number of interim prescriptions issued ............................................................................... 15 Renewal of authorisations................................................................................................... 16 Section two – patient population ............................................................................................. 18 Age of patient cohort ........................................................................................................... 19 Age and gender of patent cohort ........................................................................................ 20 Daily dose prescribed for patient cohort.............................................................................. 21 Number of takeaways per week by opioid pharmacotherapy.............................................. 23 Number of missed doses per month ................................................................................... 24 Patient cohort movement within program by gender ........................................................... 25 Section three – authorised prescribers ................................................................................... 26 Number of active prescribers by Area Health Service......................................................... 29 Section four – authorised dosing sites .................................................................................... 32 Number of dosing sites by Area Health Service .................................................................. 33 Community pharmacies by number of patients dosing ....................................................... 37 Section five – comparison data 2007–2012............................................................................ 40 Appendices............................................................................................................................... 44 Appendix 1. Community Program for Opioid Pharmacotherapy policies ................................ 44 Legislative and administrative requirements ....................................................................... 44 Appendix 2. Health Districts by postcode ............................................................................... 49 2 Appendix 3. Projected populations per Health District for adults in 2012 ............................... 51 Appendix 4. Map of approved CPOP prescribers and dosing sites in the Perth metropolitan area ........................................................................................................................................ 53 3 List of tables Table 1. Number of authorisations issued by type and opioid pharmacotherapy. ................ 12 Table 2. Number and reason for termination of authorisations ...................................... 14 Table 3. Patient cohort by age group and gender. .................................................... 20 Table 4. Number of takeaways per week by opioid pharmacotherapy ............................. 23 Table 5. Number of authorisations issued by gender ................................................. 25 Table 6. Number of patients being treated per prescriber in December 2012 ..................... 26 Table 7. Treatment by prescriber and opioid pharmacotherapy ..................................... 27 Table 8. Number of authorised community prescribers by Health District ......................... 30 Table 9. Number of authorised dosing sites by Health district ....................................... 34 Table 10. Patient cohort per 10 000 population by Area Health Service ........................... 36 Table 11. Number of patients dosing at community pharmacies and other sites in December 2012.................................................................................................... 37 Table 12. Number of authorised patients dosing by health district .................................. 38 4 List of figures Figure 1. Number of authorisations issued by opioid pharmacotherapy. ........................... 11 Figure 2. Authorisations issued by gender. ............................................................ 12 Figure 3. Authorisations issued by opioid pharmacotherapy by Area Health Service and Department of Corrective Services. ............................................................... 13 Figure 4. Number of patients dosing per month by opioid pharmacotherapy. ..................... 15 Figure 5. Number of interim prescriptions issued by specialist prescribers. ....................... 16 Figure 6. Care plan responses collected at renewal. ................................................. 16 Figure 7. Illicit drug use responses received at renewal. ............................................. 17 Figure 8. Patients authorised or receiving opioid pharmacotherapy. ............................... 18 Figure 9. Age distribution of patient cohort by opioid pharmacotherapy. ........................... 19 Figure 10. Daily dose of Subutex® and Suboxone®. .................................................. 21 Figure 11. Daily dose of methadone. ................................................................... 22 Figure 12. Number of missed doses per month by opioid pharmacotherapy ...................... 24 Figure 13. Treatment of patients by prescriber group ................................................ 27 Figure 14. Average dose of opioid pharmacotherapy by prescriber group......................... 28 Figure 15. Number of active community prescribers by Area Health Service ..................... 29 Figure 16. Patient cohort by dosing site ................................................................ 32 Figure 17. Number of dosing sites by Area Health Service .......................................... 33 Figure 18. Number of patients authorised and dosing by pharmacotherapy 2007-2012 ......... 40 Figure 19. Patients average age by pharmacotherapy 2007-2012 ................................. 41 Figure 20. Daily dose of Subutex® and Suboxone® 2007-2012 ..................................... 41 Figure 21. Daily dose of methadone 2007-2012 ...................................................... 42 Figure 22. Proportion of patients by prescriber type 2007–2012 .................................... 42 5 Executive summary The Community Program for Opioid Pharmacotherapy (CPOP) framework was developed to regulate the prescribing of opioid pharmacotherapy used for the treatment of opioid dependence in Western Australia. The Poisons Regulations 1965 set out the regulatory controls associated with the prescribing of methadone and buprenorphine (as Subutex® or Suboxone®) for the treatment of opioid dependence. This is a report for the program for 2012. There were 2969 authorisations issued from 1 January 2012 to 31 December 2012 to a total of 2601 patients – 431 authorisations were for patients as new admissions, 1242 were reauthorisations and 1296 were renewals. The Department of Health received 787 terminations which comprised of 37 patients being treated with Subutex®, 304 patients being treated with Suboxone® and 446 patients being treated with methadone. The patient cohort was defined as patients authorised and receiving a dose during 2012 (n=4095). There were 791 patients with authorisations who did not dose during 2012, and 65 patients who dosed without authorisation. In the patient cohort, 62% (n=2743) was for methadone, 34% (n=1495) for Suboxone® and 4% (n=169) for Subutex®. The average age was 35.8 years for Subutex®, 38 years for Suboxone® and 39.8 years for methadone. The largest age group seeking treatment for both gender types was in the 30 to 40 years group with 38.5 patients per 10 000 population for females and 61 patients per 10 000 population for males. The dose distribution for patients on Subutex® ranged from <1 mg to 32 mg with, an average daily dose of 12 mg. The doses most frequently prescribed were 24 mg (n=17), followed by 2 mg (n=13) and 4 mg (n=12). The dose prescribed for patients on Suboxone® ranged from 1 mg to 38 mg, with an average daily dose of 14.2 mg. The doses most frequently prescribed were 16 mg (n=156) and 8 mg (n=144), and 12 mg (n=110). The average dose distribution for patients on methadone ranged from 1 mg to 230 mg, with an average daily dose of 56.3 mg. The dose most frequently prescribed was 50 mg (n=90). As at 31 December 2012 there were 85 authorised CPOP community prescribers in WA, including 69 active and 16 inactive prescribers, and 33 active public sector prescribers (Next Step and DOCS). The largest number of patients were treated in the CPOP by community prescribers (n=2315, 55%), followed by Next Step (n=1537, 36%) and then the Department of Corrective Services (n=401, 9%). As at 31 December 2012, there were 345 community pharmacies authorised to participate in the CPOP. Of these, 250 community pharmacies dosed one or more patients, and 95 pharmacies did not dose a patient during 2012. The Department of Corrective Services has two dosing sites and dosed 549 people and Next Step Drug and Alcohol Services had one dosing and dosed 106 people. 6 Glossary of terms Term Definition AHS Area Health Service Application An ‘Application to prescribe a pharmacotherapy – CPOP’ form for an opioid dependent person, submitted to the Department of Health by authorised prescribers when initiating or changing opioid pharmacotherapy in the CPOP. Authorisation Written approval from the Chief Executive Officer or delegate for an authorised prescriber to prescribe an opioid pharmacotherapy for an opioid dependent person in accordance with the criteria set out in the Clinical policies and procedures for the use of methadone and buprenorphine in the treatment of opioid dependence. Authorised community pharmacy Community pharmacy authorised by the Chief Executive Officer or delegate to participate in the CPOP. Authorised prescriber Medical practitioner who is authorised by the Chief Executive Officer or delegate to treat opioid dependence with opioid pharmacotherapy in Western Australia. Clinical Advisory Service (CAS) A 24 hour service for all clinical matters relating to the program provided by the Drug and Alcohol Office. Community Program for Opioid Pharmacotherapy (CPOP) Framework developed to regulate the prescribing of opioid pharmacotherapy medicines for the treatment of opioid dependence in Western Australia – commenced in 1997 as the Community Methadone Program. CPOP authorisation data Data included in the ‘Application to prescribe a pharmacotherapy – CPOP’ form for an opioid dependent person submitted for authorisation by authorised prescribers and extracted from the Monitoring of Drugs of Dependence System (MODDS). DOCS Department of Corrective Services. This also includes Acacia Prison, which is managed by Serco Asia Pacific under contract with DOCS. Methadone syrup/solution Methadone syrup 5 mg/mL and methadone solution 5 mg/mL as Biodone Forte®. 7 Term Definition MODDS Monitoring of drugs of dependence database New admission A patient admitted into the CPOP for the first time. NMAHS North Metropolitan Area Health Service. Opiate pharmacotherapy dosing data Data included in the Pharmacy Report Forms submitted monthly by every dosing site in Western Australia participating in the program and extracted from the Monitoring of Drugs of Dependence System (MODDS). Opioid pharmacotherapy Collective term for methadone, Subutex® and Suboxone®, the three medicines approved for use in the CPOP. Re-authorisation Authorisation where there has been a change in prescriber, opioid pharmacotherapy or a break in treatment and/or authorisation has expired. Renewal An authorisation where there has not been any change in the prescriber’s medical practice or opioid pharmacotherapy. SMAHS South Metropolitan Area Health Service. Suboxone® Buprenorphine with naloxone sublingual tablet or film available in two strengths – 2 mg and 8 mg with a 4:1 ratio of buprenorphine to naloxone. Subutex® Buprenorphine sublingual tablet available in three strengths – 0.4 mg, 2 mg and 8 mg. Termination Notification of cessation of treatment with opioid pharmacotherapy for a specified patient by an authorised prescriber. Treatment provider Prescriber authorised to participate in CPOP who may practice at Next Step, in the community or Department of Corrective Services. WACHS Western Australian Country Health Service. WA Clinical policies and procedures for the use of methadone and buprenorphine in the treatment of opioid dependence Document which sets out the policies of the program for the prescribing of opioid pharmacotherapy in Western Australia underpinned by the Poisons Regulations 1965. Regulation 51A refers to the ‘Policies Manual’ 8 Overview Introduction Prior to 1997 the provision of opioid pharmacotherapy for the treatment of opioid dependence was only available through a single government service operated by the WA Alcohol and Drug Authority. The Community Program for Opioid Pharmacotherapy (CPOP) commenced in 1997 as the Community Based Methadone Program (CMP) in Western Australia (WA) and was restricted to methadone syrup. It was renamed CPOP when buprenorphine, as Subutex® sublingual tablets, became available for the treatment of opioid dependence in 2001. Buprenorphine with naloxone (4:1 ratio) as Suboxone ® sublingual tablets became available in May 2006 and Suboxone® sublingual film in September 2011. The methadone and buprenorphine used in the CPOP is funded by the Commonwealth Government through outlets authorised by the Department of Health, Western Australia. Supply is predominately through community pharmacies. This is the seventh report of the CPOP and covers the period 1 January 2012 to 31 December 2012. Opioid pharmacotherapy prescribing in WA The WA Clinical policies and procedures for the use of methadone and buprenorphine in the treatment of opioid dependence (Policies Manual) sets out the policies and procedures for the prescribing of methadone syrup/solution, Subutex® and Suboxone® sublingual tablets/film in WA (Appendix 1). The policies are underpinned by the Poisons Regulations 1965. Treatment with methadone syrup/solution, Subutex® and Suboxone® sublingual tablets/film for opioid dependence can only be initiated by an authorised CPOP prescriber. Each patient requires prior authorisation from the Chief Executive Officer for treatment with an opioid pharmacotherapy and supply is only through an authorised dosing site. Methodology The Department of Health maintains records relating to the CPOP in the Monitoring of Drugs of Dependence System (MODDS), which includes the CPOP authorisation data and the opiate pharmacotherapy dosing data provided by participating pharmacies or dosing sites. The patient application form for CPOP authorisation contains the following information used in this report: patient’s address postcode, date of birth, gender authorised CPOP prescriber details authorised dosing site details opioid pharmacotherapy, form, and maximum dose. 9 For the purpose of the report, age was calculated as at 31 December 2012. The opiate pharmacotherapy dosing data contains the following information used in this report: opioid pharmacotherapy received month and year of treatment dose (as at the last day of dosing during the month) number of missed doses during the specified month number of takeaways received during the specified month. Data were extracted from the CPOP authorisation and opiate pharmacotherapy dosing data for the period 1 January 2012 to 31 December 2012. As there is a time lag in the collection of data from dosing sites, the opiate pharmacotherapy dosing data was extracted from MODDS on 16 July 2013. Patients were assigned to an Area Health Service (AHS) and Health District based on the postcode of the address listed on the authorisation application form as at the extraction date. Postcodes were allocated to an AHS and Health District based on information provided by the Epidemiology Branch of the Department of Health. Postcodes per Health District are included in Appendix 2. Age specific rates per 10 000 population were calculated using Rates Calculator Version 9.5.4 (Jim Codde, 1993–2005) provided by the Epidemiology Branch of the Department of Health. Projected populations by Health District are in Appendix 3. 10 2012 results Section one – authorisations issued Number of authorisations issued As at 31 December 2012, there had been 10 208 patients admitted to the program since the commencement of the community-based program in 1997. There had been 3378 (22.3%) patients authorised to receive Subutex®; 8130 (53.6%) patients authorised to receive methadone; and 3652 (24.1%) patients authorised to receive Suboxone®. Since the commencement of the program there had been 29 641 authorisations issued. The majority of the authorisations issued have been for methadone (n=18 553, 62.6%), followed by Subutex® (n=5637, 19.9%) and Suboxone® (n=5451, 18.4%) There were 2969 authorisations issued from 1 January 2012 to 31 December 2012, to a total of 2601 patients. An authorisation is issued for a patient entering the program and each time the patient changes treatment provider and/or opioid pharmacotherapy. Therefore a patient may receive more than one authorisation during the year and be counted in more than one opioid pharmacotherapy group. Figure 1. Number of authorisations issued by opioid pharmacotherapy. Subutex, n=115, 4% Suboxone, n=1081, 36% Methadone, n=1773, 60% Figure 1 shows the breakdown of the 2969 authorisations issued during 2012 in the CPOP. Methadone (n=1773, 60%) continues to be used in preference to buprenorphine as Subutex® or Suboxone® (n=1196, 40%). 11 Authorisation type and opioid pharmacotherapy Table 1. Number of authorisations issued by type and opioid pharmacotherapy. Authorisation Number of authorisations Total type Subutex® Suboxone® Methadone New admission 6 221 204 431 Re-authorisation 61 476 705 1242 Renewals 48 384 864 1296 Total 115 1081 1773 2969 Table 1 provides a breakdown of the type of authorisation issued by the type of opioid pharmacotherapy. A new admission is a patient who was authorised in CPOP for the first time. Re-authorisation occurs where there has been a change in the prescriber, opioid pharmacotherapy or a break in treatment and/or the authorisation has expired and requires a new application. Renewal is required when there has been no change in the prescriber’s medical practice or pharmacotherapy for a patient authorised in the CPOP. A patient may have received multiple authorisations during the year by moving to a new prescriber or changing opioid pharmacotherapy. Authorisations issued by gender Percentage of authorisations Figure 2. Authorisations issued by gender. 100% 80% n=47 (42%) 60% 40% 20% n=65 (58%) n=653 (63%) n=1025 (63%) n=379 (37%) n=600 (37%) Suboxone Methadone 0% Subutex Female Male Figure 2 shows the gender breakdown for the different opioid pharmacotherapies. Of the 112 patients with authorisations issued in 2012 for Subutex®, 58% (n=65) were for females and 42% (n=47) were for males; for Suboxone®, 37% (n=379) were for females and 63% (n=653) were for males; and for methadone, 37% (n=600) were for females and 63% (n=1025) were for males. In contrast with methadone and Suboxone®, there were a higher percentage of females 12 authorised for Subutex®, which is due to the conditional use of this medicine during pregnancy and breastfeeding for female patients. Female patients who become pregnant or are breastfeeding are switched from Suboxone® to Subutex® in line with the Policies Manual. The 47 male patients received Subutex® in line with the accepted exception conditions on the application form for Subutex®, which include continuing treatment without takeaways, known allergy to Suboxone®, and low dose treatment (6 mg or less). Authorisations issued by Area Health Service No of authorisations Figure 3. Authorisations issued by opioid pharmacotherapy by Area Health Service and Department of Corrective Services. 800 700 600 500 400 300 200 100 0 38% 36% 39% 40% 17% 18% 54% NMAHS Subutex 35% 12% SMAHS WACHS Suboxone 8% 0% 3% DOCS Methadone Figure 3 shows the distribution of authorisations issued according to the patient’s postcode by opioid pharmacotherapy across the AHS and the DOCS. Most of the CPOP authorisations were issued to patients residing within North and South Metropolitan Health Services, providing the combined totals of: Subutex® (n=99, 89%), Suboxone® (n=816, 79%) and Methadone (n=1211, 74%). 13 Termination of authorisations Authorised prescribers are required to notify the Department of Health when a patient is no longer receiving treatment from the prescriber. A termination notification is not required when changing pharmacies. The termination form provides the prescriber with a list of 11 reasons for the termination. Table 2. Number and reason for termination of authorisations Reason Subutex® Suboxone® Methadone Total Mutual agreement 4 21 29 54 Left against advice 0 14 16 30 Did not commence 1 4 5 10 Ceased to pick up 3 93 114 210 Involuntary discharge 0 3 2 5 Deceased 1 2 20 23 Intrastate transfer 6 41 66 113 Interstate transfer 1 8 31 40 Detoxified 7 41 41 89 Imprisoned 1 20 43 64 Others 13 57 79 149 Total 37 304 446 787 Table 2 provides a summary of the termination reasons notified to the Department of Health by opioid pharmacotherapy prescribers. There were 787 termination forms received by the Department of Health from prescribers providing information relating to the reason for termination. 14 Patients dosing by opioid pharmacotherapy Figure 4. Number of patients dosing per month by opioid pharmacotherapy. No of patients 2400 2000 1600 1200 800 400 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Suboxone Subutex Nov Dec Methadone Note: a patient may be counted more than once during a month as they may change opioid pharmacotherapy and or dosing site. In January 2012 there were a total of 3655 dosing in the CPOP. In December 2012 there were 3669 patients dosing in CPOP, an increase of 14 patients. Between 1 January 2012 and 31 December 2012 the number of patients dosing methadone decreased (n=45), the number of patients dosing Subutex® decreased (n=2) and Suboxone® increased (n=61). Number of interim prescriptions issued There are instances when a patient may need to travel unexpectedly or their dosing prescription may have expired. If their CPOP prescriber is not available to issue a prescription then the Clinical Advisory Service (CAS) or the Community Pharmacotherapy Program (CPP) can be contacted to provide ongoing treatment for patients participating in the CPOP. An interim prescription is written by the specialist prescriber at CPP only when the patients authorised prescriber is not available and it is safe to do so. The prescription can be for up to one month and the patient must be seen by their authorised CPOP prescriber when available for ongoing treatment as soon as possible. As at 31 December 2012, there were 929 interim prescriptions written by specialist prescribers. 15 Figure 5. Number of interim prescriptions issued by specialist prescribers. Subutex, n=11, 1% Suboxone, n=258, 28% Methadone, n=660, 71% Renewal of authorisations As at 31 December there were 922 renewals processed. An authorised prescriber is required to complete an application for authorisation renewal when a patient has been in continuous treatment with an opioid pharmacotherapy for two years. The prescriber indicates on the renewal the care plan for the patient during the next six months. They will either: continue maintenance treatment – no change, commence withdrawal, or plan to withdraw from treatment. This is a new data element, and 83% of the patients who were renewed for a further two years where continuing in maintenance treatment for the next six months. Figure 6. Care plan responses collected at renewal. Plan Withdrawal, n=65, 7% Commence Withdrawal, n= 88, 10% No Plan Reported, n=14, 2% Continue Maintenance, n=755, 83% 16 Figure 7. Illicit drug use responses received at renewal. Not Reported, n=17, 2% Illicit Drugs , n=65, 7% No Illicit Drug, n=840, 91% Figure 7 shows that of the 922 renewals received illicit drugs use was reported in 7% of cases. 17 Section two – patient population Data were extracted from the opiate pharmacotherapy dosing records in the MODDS database and compared with the CPOP authorisation records. Figure 4 shows the number of patients for each authorisation and dosing combination from 1 January 2012 to 31 December 2012. There were 4886 patients authorised during 2012. Of these, 83.8% (n=4095) of patients were authorised and dosed during 2012, and 16.2% (n=791) of patients were authorised but did not dose during 2012. In 2012 there were 65 patients who dosed without a current authorisation. In all cases the authorisation had expired. The Department of Health has followed up these patients and they have been excluded from further analysis in this report. The patients who were authorised and dosing during 2012 (n=4095) will be the patient cohort referred to in the remainder of this section. Figure 8. Patients authorised or receiving opioid pharmacotherapy. Authorised (n=4886) Patients authorised and not dosing n=791 Dosing (n=4160) Patients authorised and dosing Total(n=4095) Methadone(n=2743) Subutex(n=169) Suboxone(n=1495) Patients not authorised and dosing n=65 Figure 8 shows the total number of authorised patients (n=4,886), the total number of patients dosing (n=4160) and the patient cohort (n=4095). In the patient cohort, 62% (n=2743) was for methadone, 34% (n=1495) for Suboxone® and 4% (n=169) for Subutex®. The total number of patients in the cohort counted by opioid pharmacotherapy breakdown (n=4407) is a larger number than the patient cohort, as patients can be counted more than once due to changing opioid pharmacotherapy during the year. 18 Age of patient cohort No of patients Figure 9. Age distribution of patient cohort by opioid pharmacotherapy. 160 140 120 100 80 60 40 20 0 17 21 25 29 33 37 41 45 49 53 57 61 65 Age Subutex Methadone Suboxone Figure 9 shows the age distribution of patients in the cohort by opioid pharmacotherapy. The average age was 35.8 years for Subutex®, 38 years for Suboxone® and 39.8 years for methadone. The most common age was 31 years for Subutex®, 34 years for Suboxone® and 33 years for methadone. The minimum ages of patients receiving opioid pharmacotherapies were 23 years for Subutex®, 17 years for Suboxone® and 18 years for methadone. The maximum ages of patients were 59 years for Subutex®, 69 years for Suboxone® and 67 years for methadone. 19 Age and gender of patent cohort The age specific rate per 10 000 people was calculated by analysing the patient cohort by age group and gender. The population denominator is the number of people in the age range specified. Table 3. Patient cohort by age group and gender. Age category Patient Rate per 10 000 frequency population Female ≥18 and <25 47 4.0 ≥25 and <30 173 18.9 ≥30 and <40 660 38.5 ≥40 and <50 432 25.1 ≥50 and <60 216 14.0 ≥60 11 0.5 Total female 1540 Male ≥18 and <25 62 4.9 ≥25 and <30 225 22.7 ≥30 and <40 1112 61.0 ≥40 and <50 712 39.9 ≥50 and <60 397 25.3 ≥60 47 2.2 Total male 2555 Table 3 shows that 38% (n=1540) of the patient cohort is female and 62% (n=2555) is male. In both gender groups, the highest rate per 10 000 population is in the age group between 30 to 40 years old (female=38.5 and male=61.0). 20 Daily dose prescribed for patient cohort No of patients Figure 10. Daily dose of Subutex® and Suboxone®. 180 160 140 120 100 80 60 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 Dose (mg) Subutex Suboxone The dose distribution for patients on Subutex® ranged from <1 mg to 32 mg, with an average dose of 12 mg. The largest number of patients for Subutex® were on a dose of 24 mg (n=17), followed by 2 mg (n=13) and 4 mg (n=12). The dose distribution for patients on Suboxone® ranged from 1 mg to 38 mg, with an average dose of 14.2 mg. The largest number of patients were receiving 16 mg (n=156), followed by 8 mg (n=144) and 12 mg (n=110). Suboxone® is available as 8 mg and 2 mg sublingual tablets and film and Subutex® is available as a 400 microgram, 2mg and 8mg sublingual tablet. The maximum daily dose approved for buprenorphine as Subutex® and Suboxone® is 24 mg as per the WA Clinical policies and procedures for the use of methadone and buprenorphine in the treatment of opioid dependence. If a patient received a dose every second day then the maximum dose in one day should not exceed 32 mg. For example, a patient dosing 14mg daily would be recorded as 28mg if dosed every second day. However, the pharmacy dosing reports provided to the Department of Health do not indicate if the dosing is daily, second or third daily dosing. All analysis on dosing is based on an assumption of daily dosing. 21 No of patient Figure 11. Daily dose of methadone. 100 90 80 70 60 50 40 30 20 10 0 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 Average Dose (mg) Methadone Figure 11 shows the average daily dose (the sum of the reported doses, divided by the number of months dosed) of methadone received by patients. The dose distribution for patients on methadone ranged from 1 mg to 230 mg with an average dose of 56.3 mg daily. The largest number of patients were on 50 mg (n=90) daily. The maximum dose of methadone that can be prescribed without special approval is 120 mg. There were 26 patients receiving a dose greater than 120 mg where authorisation has been approved following receipt of an ‘Application to prescribe outside the guidelines’ for an opioid dependent person. 22 Number of takeaways per week by opioid pharmacotherapy A pharmacy dosing report is completed each month by pharmacies participating in the CPOP and sent by fax or email to the Department of Health. This report provides the total number of takeaways dispensed during the month for each patient. This number was divided by 4 to provide an average number of takeaways per week. Patients who received less than an average of 1 takeaway per week were placed in the <1 category. This category also includes patients who received takeaways only during extended holiday periods such as Christmas and Easter, or other exceptional circumstances. Table 4. Number of takeaways per week by opioid pharmacotherapy Patient frequency Average number of takeaways Subutex Suboxone Methadone Total 0 87 798 1235 2120 <1 5 71 151 227 1 44 318 468 830 2 24 229 459 712 3 9 61 341 411 4 0 11 70 81 5 0 5 14 19 6 0 2 3 5 7 0 0 2 2 Total 169 1495 2743 4407 Table 4 shows 48.8% (n=2103) of patients did not receive a takeaway and 6.6% (n=284) received on average less than one takeaway per week. The program allows a maximum of two takeaways per week for Suboxone ®. There were 6.3% (n=89) patients receiving more than the policy supports. There were 38% (n=66) patients who had received one or more takeaways for Subutex®. This group includes those patients receiving low dose (6 mg or less for 6 months only), pregnant and breastfeeding women and those allergic to Suboxone ®. The program allows a maximum of three takeaways per week for methadone. There were 4.6% (n=124) receiving more than the policy supports. For those patients receiving more than the maximum number of takeaways an application is completed by the prescriber and forwarded to the Community Pharmacotherapy Program (CPP) for consideration and support before prescribing. 23 Number of missed doses per month The pharmacy dosing reports forwarded monthly to the Department of Health from community pharmacies provide the number of missed doses during the month for each patient dosing. The average number of missed doses per month was calculated by adding the number of missed doses for each month a patient dosed and dividing by the number of dosing months. No of patient Figure 12. Number of missed doses per month by opioid pharmacotherapy 2000 1800 1600 1400 1200 1000 800 600 400 200 0 62% 26% 40% 37% 14% 8% 53% 35% 0 4% 8% ≥1 and ≤5 >5 and ≤10 9% 4% >10 Average number of missed doses per month Subutex Suboxone Methadone Figure 12 shows that of the total patients in treatment, a large proportion did not miss a dosing day during their treatment period for all three opioid pharmacotherapies: methadone 62% (n=1709), Suboxone® 40% (n=605) and Subutex® 53% (n=90) of patients. The remainder of patients in treatment were grouped according to the number of doses missed. Patients who missed one to five doses were: methadone 26% (n=723), Suboxone® 37% (n=556) and Subutex® 35% (n=59). Patients who missed more than five to ten doses were: methadone 8% (n=209), Suboxone® 14% (n=203) and Subutex® 8% (n=13). Patients who missed more than 10 doses were: methadone 4% (n=102), Suboxone® 9% (n=131) and Subutex® 4% (n=7). The reporting of missed doses should be viewed with caution, as at the time of submitting the pharmacy monthly dosing report to the Department of Health, a pharmacist may not be aware if the patient has missed a dose or ceased treatment. In some instances the reported missed dose may be incorrect as the patient may have moved pharmacies. 24 Patient cohort movement within program by gender Each patient in the cohort was classified according to the number of authorisations issued during 1 January 2012 to 31 December 2012. A new authorisation is issued when a patient changes opioid pharmacotherapy, treatment provider or the previous authorisation has expired. An authorisation that is renewed without a break in treatment does not constitute a new authorisation and has not been included in this analysis. Table 5. Number of authorisations issued by gender Classification Female Female Male frequency percentage frequency Male Frequency percentage total 1 Authorisation 1246 80.9% 2075 81.2% 3321 2 Authorisations 222 14.4% 382 15.0% 604 3 Authorisations 61 4.0% 79 3.1% 140 4 Authorisations 10 0.6% 16 0.6% 26 >4 Authorisations 1 0.1% 3 0.1% 4 Total 100.0% 2555 100.0% 4095 1540 Table 5 shows the frequency of authorisations issued per patient in 2012 by gender. It highlights the extent of switching between opioid pharmacotherapies and movement between prescribers by patients within the program. Around 81% of both males (n=2075) and females (n=1246) had one authorisation only. 25 Section three – authorised prescribers In 2012, there were 85 authorised community CPOP prescribers in WA, including 69 active and 16 inactive community prescribers. Inactive prescribers were those who did not prescribe opioid pharmacotherapy during the period 1 January 2012 to 31 December 2012. The Next Step Drug and Alcohol Services utilised 21 active prescribers in three public clinics. The Department of Corrective Services utilised 12 active authorised prescribers employed in the prison system. Next Step and DOCS prescribers may be included in the community prescribers’ category if they also practice privately. During 2012, 13 new prescribers where authorised to participate in the CPOP. Table 6. Number of patients being treated per prescriber in December 2012 Patient No. of approved Percentage Cumulative frequency CPOP percentage of patients prescribers ≥1 and ≤5 30 35.7% 35.7% >5 and ≤10 15 17.9% 53.6% >10 and ≤20 16 19.0% 72.6% >20 and ≤50 11 13.1% 85.7% >50 and ≤100 8 9.5% 95.2% >100and<150 0 0.0% 95.2% >150 4 4.8% 100.0% Total 84 100% Table 6 shows the number of patients treated per active CPOP prescriber according to dosing record data for December 2012. Prescribers at Next Step Drug and Alcohol Services and Department of Corrective Services were excluded from this analysis The number of patients per prescriber ranged from one to 369. Of the 30 authorised prescribers treating between one and five patients, 14 authorised prescribers treated one patient only. There were four authorised prescribers who treated more than 100 patients. The average number of patients per prescriber was 27 and the median number of patients was 10. 26 Treatment of patients by prescriber The number of patients treated by the different prescriber groups is shown in Figure 13. A patient may have been treated by more than one prescriber group and is counted in each group. It indicates the participation of the three prescriber groups involved in the treatment of the patient cohort. Figure 13. Treatment of patients by prescriber group Next Step prescriber, n=1537, 36% Community prescriber, n=2315, 55% DOCS prescriber, n=401, 9% Figure 13 shows that during 2012, 55% (n=2315) of patients in of the cohort were treated by community prescribers, 36% (n=1537) by Next Step prescribers and 9% (n=401) by prescribers at the Department of Corrective Services. The total (n=4253) is greater than the patient cohort due to the movement of patients between prescriber groups. Table 7. Treatment by prescriber and opioid pharmacotherapy Prescriber type Community prescriber DOCS prescriber Next Step prescriber Subutex® Patient frequency % 92 3.7% 1 0.2% 75 4.6% Suboxone® Patient frequency % 940 38.2% 41 9.7% 535 32.6% Methadone Patient frequency % 1428 58.0% 382 90.1% 1030 62.8% Table 7 shows the different opioid pharmacotherapy being used by each prescriber group. DOCS prescribers treated 90.1% (n=382) of patients with methadone, Next Step prescribers 62.8% (n=1030) and community prescribers 58% (n=1428). 27 Figure 14. Average dose of opioid pharmacotherapy by prescriber group Mean average dose (mg) 80.0 70.0 60.5 60.0 54.6 53.1 50.0 40.0 30.0 20.0 12.4 16.0 12.0 10.0 16.3 13.2 8.3 0.0 Subutex Community Prescriber Suboxone DOCS Prescriber Methadone Next Step Prescriber Figure 14 shows the different drug and doses prescribed by prescriber groups. The average dose is calculated as the sum of the last dose of each month provided by the dosing site (in milligrams) divided by the total number of months dosed. The average dose of Subutex® prescribed by the community prescribers (12.4 mg) is similar to those prescribed by Next Step (12 mg). The higher average doses of Suboxone® and methadone prescribed by Next Step may represent a more complex patient group being treated. 28 Number of active prescribers by Area Health Service Figure 15. Number of active community prescribers by Area Health Service WACHS, n=47, (45.2%) NMAHS, n=37, (35.6%) SMAHS, n=20, (19.2%) Figure 15 shows the number of active prescribers by Area Health Service. The total number of active community prescribers (n=104) is larger than the number of active community prescribers (n=85), as a prescriber may practice in more than one Area Health Service, or may have moved practice during 2012. Prescribers at Next Step Drug and Alcohol Services and Department of Corrective Services were excluded from this analysis. The distribution of prescribers in the Perth metropolitan area in 2012 is provided in Appendix 4. 29 Table 8. Number of authorised community prescribers by Health District Number of approved active CPOP Area Health Service Health District prescribers Bayswater-Bassendean 3 Joondalup 1 Kalamunda 0 Oceanic 23 Stirling Coastal 0 Stirling SEC 5 Valley and Hills 5 Wanneroo 3 Armadale 3 Bentley 3 Fremantle 5 Peel 8 Rockingham-Kwinana 1 Blackwood 1 Bunbury 6 Busselton 3 Central Great Southern 0 East Pilbara 4 Eastern Wheatbelt 0 Gascoyne 2 Geraldton 11 Kimberley 1 Leeuwin 1 Leschenaults 0 Lower Great Southern 3 Midwest 0 NMAHS SMAHS WACHS 30 Area Health Service Health District Number of approved active CPOP prescribers Murchison 0 Northern Goldfields 3 South East Coastal 5 Southern Wheatbelt 1 Warren 0 Wellington 0 West Pilbara 1 Western Wheatbelt 2 Total 104 WACHS Table 8 shows the number of active authorised community prescribers in the program. Prescribers may be counted more than once if they practice in more than one location or have moved practices during 2012. The number of active authorised prescribers by Health District ranged from 0 to 23. The data does not include DOCS and Next Step prescribers. 31 Section four – authorised dosing sites As at 31 December 2012, there were 345 community pharmacies authorised to participate in the CPOP. There were 250 community pharmacies dosing one or more patients and 95 pharmacies had not dosed a patient during 2012. The Department of Corrective Services has two dosing sites and Next Step Alcohol and Drug Services has one dosing site located at East Perth. There were seven dosing sites not included in the above categories, these comprised Regional Hospitals and Nursing Posts included in the ‘Others’ category where 45 patients dosed during the year. Figure 16. Patient cohort by dosing site Next Step, n=106, 2.4% Others, n=45, 1.0% DOCS, n=549, 12.2% Community pharmacy, n=3794, 84.4% Figure 16 shows the number of patients by dosing site. The total number of patients dosing (n=4494) is greater than the number of patients in the cohort as a patient may have dosed at more than one type of dosing site. Community pharmacies were responsible for 84% (n=3794) of the CPOP dosing, Department of Corrective Services for 12% (n=549) and Next Step for 3% (n=106). Other sites accounted for 1% (n=45). 32 Number of dosing sites by Area Health Service Figure 17. Number of dosing sites by Area Health Service WACHS, n=88, (30.3%) NMAHS, n=112, (38.6%) SMAHS, n=90, (31.0%) Figure 17 shows the number and percentage of dosing sites by Area Health Service. North Metropolitan has the largest number of dosing sites 39% (n=112), followed by South Metropolitan 31% (n=90) and WA Country 30% (n=88). Both active and inactive dosing sites have been included. DOCS dosing sites have been excluded. 33 Table 9. Number of authorised dosing sites by Health district Number of approved Area Health Service Health district CPOP dosing centres Bayswater-Bassendean 10 Joondalup 15 Kalamunda 7 Oceanic 38 Stirling Coastal 12 Stirling SEC 23 Valley and Hills 17 Wanneroo 15 Armadale 17 Bentley 26 Fremantle 36 Peel 12 Rockingham-Kwinana 17 Blackwood 5 Bunbury 8 Busselton 7 Central Great Southern 2 East Pilbara 3 Eastern Wheatbelt 6 Gascoyne 3 Geraldton 5 Kimberley 5 Leeuwin 3 Leschenaults 3 Lower Great Southern 9 Midwest 4 Murchison 0 NMAHS SMAHS WACHS 34 Area Health Service WACHS Health district Number of approved CPOP dosing centres Northern Goldfields 6 South East Coastal 5 Southern Wheatbelt 6 Warren 5 Wellington 1 West Pilbara 8 Western Wheatbelt 14 Total 353 Table 9 shows the number of authorised dosing sites by Health District ranged from 0 to 38. The data excludes DOCS dosing sites. The distribution of dosing sites in the Perth metropolitan area in 2012 is provided in Appendix 4. 35 Table 10. Patient cohort per 10 000 population by Area Health Service Patient Rates per 10,000 Area Health Service frequency population NMAHS 1594 20.4 SMAHS 1591 22.9 WACHS 688 16.5 Total 3873 Table 10 shows the number and rate per 10 000 population of the patient cohort in each of the three area health services. Patients were assigned to an Area Health Service (AHS) based on the postcode of the address on the authorisation application form. The patients being treated at DOCS are not included in this analysis. 36 Community pharmacies by number of patients dosing The dosing records for December 2012 provided to the Department of Health by community pharmacies and others were used to group the number of patients. Patients may have moved pharmacy or changed opioid pharmacotherapy during the month and therefore may be counted more than once. Table 11. Number of patients dosing at community pharmacies and other sites in December 2012 Patient Percentage Cumulative Number of frequency of patients percentage community pharmacies and others ≥1 and ≤5 89 37.1% 37.1% >5 and ≤10 51 21.3% 58.5% >10 and ≤20 55 22.9% 81.3% >20 and ≤50 36 15.0% 96.3% >50 9 3.8% 100.0% Total 240 100.0% Table 11 shows that around 40% of the community pharmacies dosed between one and five patients (n=89). There were 24 community pharmacies which only have one patient dosing. The number of patients dosing at a community pharmacy during the month of December 2012 ranged from one to 171. Community pharmacies report the last dose dispensed during the reporting month. Transient patients may be recorded as dosing at more than one pharmacy during a month. Community pharmacies dosing transient patients will reflect a higher number recorded each month. The average number of patients was 13.8 and median 8.0 per community pharmacy. The maximum number of patients supported by the program per community pharmacy is 50. The nine community pharmacies dosing more than 50 patients had made application to the CPOP Management Committee and received approval to do so. 37 Table 12. Number of authorised patients dosing by health district Patient Area Health Service Health district frequency Rates per 10 000 population Bayswater-Bassendean 183 28.7 Joondalup 164 12.5 Kalamunda 47 10.8 Oceanic 315 24.6 Stirling Coastal 118 19.9 Stirling SEC 327 30.1 Valley and Hills 266 21.9 Wanneroo 240 19.1 Armadale 243 16.3 Bentley 390 23.0 Fremantle 463 24.9 Peel 234 29.1 Rockingham-Kwinana 260 23.9 Blackwood 3 4.7 Bunbury 102 25.6 Busselton 83 29.5 Central Great Southern 7 8.2 East Pilbara 19 9.3 Eastern Wheatbelt 7 6.9 Gascoyne 22 30.2 Geraldton 56 18.7 Kimberley 17 5.4 Leeuwin 18 16.9 Leschenaults 21 6.7 Lower Great Southern 93 22.3 Midwest 7 6.7 Murchison 1 3.9 NMAHS SMAHS WACHS 38 Area Health Service WACHS Health district Patient frequency Rates per 10 000 population Northern Goldfields 42 14.0 South East Coastal 43 36.3 Southern Wheatbelt 13 8.1 Warren 10 12.6 Wellington 11 9.4 West Pilbara 14 5.9 Western Wheatbelt 33 12.4 Total 3872 Table 12 shows the number of authorised patients by health district ranged from one to 463 patients. This does not include DOCS patients. 39 Section five – comparison data 2007–2012 This section provides comparative information on the CPOP between 2007 and 2012. Data from the first annual report published in 2006 has not been included. Suboxone® first became available in Western Australia on 1 May 2006. At this time in 2006 many patients authorised and dosing with Subutex® and receiving takeaways were transferred to Suboxone ®. Figure 18. Number of patients authorised and dosing by pharmacotherapy 2007-2012 No of patients 3000 2000 1000 0 2007 2008 2009 2010 2011 2012 Suboxone 1062 1200 1359 1401 1412 1495 Subutex 276 229 189 180 173 169 Methadone 2469 2595 2756 2777 2722 2743 Year Suboxone Subutex Methadone Figure 18 shows a reduction in CPOP patients treated with Subutex and an increase in patients treated with Suboxone between 2007 and 2012, in line with the policies of the program. 40 Average age Figure 19. Patients average age by pharmacotherapy 2007-2012 42 40 38 36 34 32 30 Suboxone Subutex Methadone 2007 2008 2009 2010 2011 2012 34.7 35 35.8 36.7 37.4 38 34 34.2 34.5 34.3 35.1 35.8 36.6 36 37.8 38.3 38.9 39.8 Year Suboxone Subutex Methadone Figure 19 shows that between 2007 and 2012 there was an increase in the average age of the patients authorised and dosing in the CPOP for all three pharmacotherapies. Average dose (mg) Figure 20. Daily dose of Subutex® and Suboxone® 2007-2012 14.5 14 13.5 13 12.5 12 11.5 11 10.5 2007 2008 2009 2010 2011 2012 Suboxone 13.1 13.1 14 14.1 13.8 14.2 Subutex 12.2 12 13.2 12.2 12.7 12 Year Suboxone Subutex 41 Figure 20 shows that between 2007 and 2012 the average daily dose of Suboxone in the CPOP has increased each year and over the six year period increased from 13.1 mg to 14.2 mg. This represents an increase of 1.1 mg (8.4%). The average daily dose of Subutex in the CPOP has fluctuated by year, but remained stabled over this time. Figure 21. Daily dose of methadone 2007-2012 Average dose (mg) 58.5 58 57.5 57 56.5 56 55.5 55 Methadone 2007 2008 2009 2010 2011 2012 56.4 57.8 58.3 57.6 56.1 56.3 Year Methadone Figure 21 shows the average daily dose of methadone for all CPOP patients by year between 2007 and 2012. The average daily dose of methadone increased between 2007 and 2009 (1.9mg, 3.4%), and decreased between 2009 and 2011. 42 Figure 22. Proportion of patients by prescriber type 2007–2012 Percentage of patient 60 50 40 30 20 10 0 2007 2008 2009 2010 2011 2012 Year Next Step DOCS Community Figure 22 shows percentage of the total number of CPOP patients treated by each prescriber group each year between 2007 and 2012. The proportion of patents treated by each group has remained relatively constant over this time period. 43 Appendices Appendix 1. Community Program for Opioid Pharmacotherapy policies The following information is extracted from the WA Clinical policies and procedures for the use of methadone and buprenorphine in the treatment of opioid dependence. Visit www.dao.health.wa.gov.au for the full text. Legislative and administrative requirements Legislative requirements The legislative framework for the Community Program for Opioid Pharmacotherapy is contained in the Poisons Regulations 1965. Medical Practitioners require prior authorisation from the Chief Executive Officer to prescribe methadone and buprenorphine for the treatment of dependence and in addition the authorised prescriber must obtain an individual patient authority from the Chief Executive Officer, before prescribing methadone or buprenorphine to a drug dependent person. The Drugs of Addiction Notification Regulations 1980 also require a medical practitioner who in the course of her or his practice becomes aware of or suspects a person of being addicted to drugs, to inform the Executive Director Public Health. The following legislative requirements apply. Authorisation as a methadone/buprenorphine prescriber in Western Australia Medical practitioners who provide methadone and/or buprenorphine treatment for opioid dependence must be authorised by the Chief Executive Officer under Regulation 51C of the Poisons Regulations 1965. A prescriber completes an application to become an approved methadone/buprenorphine prescriber. The medical practitioner is required to satisfactorily complete a training and assessment package delivered by the Drug and Alcohol Office (DAO) and make a commitment to comply with clinical policies and procedures, codes of practice and administrative instructions of the program. The Drug and Alcohol Office will notify the Department of Health that the prescriber has satisfactorily completed the training and assessment requirements. Authorisation as a methadone/buprenorphine dispenser in Western Australia Pharmacies participating in the dispensing of methadone/buprenorphine for opioid dependence must be authorised by the Chief Executive Officer under Regulation 51EA of the Poisons Regulations 1965. The pharmacy proprietor is required to complete an ‘Application to Participate in Methadone/Buprenorphine Dispensing’. The proprietor must agree that all pharmacists participating in the CPOP have successfully completed the training and assessment package and that the minimum standards for the dispensing of methadone/buprenorphine have been implemented in the pharmacy. The Department of Health issues an authorisation for the pharmacy for participation in the dispensing of methadone/buprenorphine and notifies the nominated wholesaler that the 44 pharmacy is participating in the CPOP and eligible for methadone/buprenorphine free of charge (recording fee still applies). Authority to prescribe Authorised methadone/buprenorphine prescribers must obtain from the Chief Executive Officer or delegate an individual patient authority for each patient being commenced on treatment under Regulation 51CA of the Poisons Regulations 1965. An ‘Application to prescribe a pharmacotherapy – CPOP’ form for an opioid dependent person is completed by the prescriber. The patient must also sign the application to indicate that they acknowledge that the information will be forwarded to the Department of Health and used for the management of the program. The completed ‘Application to prescribe a pharmacotherapy – CPOP’ form for an opioid dependent person is forwarded to the Clinical Advisory Service (CAS) and the authorisation is issued by the Department of Health. Specialist prescribers at Next Step may make direct application to the Department of Health although they may consult the Clinical Advisory Service if the need arises. An authorisation number must be obtained prior to the writing of a prescription for methadone or buprenorphine. Authorisation is for a maximum maintenance dose of 120 mg of methadone or 24 mg of buprenorphine. The number of takeaways authorised on a prescription must be in accordance with the ‘Takeaway Policy’ (see below). On completion the application form and record of the authority number should be filed with the patient’s records. Please note–an ‘Application to prescribe a pharmacotherapy – CPOP’ form for an opioid dependent person is required when initiating prescribing for a patient transferring from another prescriber or for a patient that has previously been treated by the same prescriber but the authorisation has expired or been terminated. Conditions associated with the authority to prescribe opioid pharmacotherapy The authorisation for a medical practitioner to prescribe methadone or buprenorphine is subject to the following conditions. Legal responsibility The prescriber is legally responsible for the treatment of a patient until treatment is transferred or terminated. Patient numbers policy The prescriber must not exceed the maximum number of patients set out below. Patient numbers per approved prescriber When approved as a methadone or buprenorphine treatment prescriber a medical practitioner will be authorised to prescribe for a maximum of 150 clients at any one time. To exceed this number a prescriber may apply in writing to the Pharmaceutical Services Branch of the Department of Health. The Department of Health will forward the application to the CPOP Management Committee for review. The CPOP Management Committee will make a recommendation to the Chief Executive Officer whether to increase the prescribers’ patient numbers to a maximum of 200. In assessing the application consideration the record of the prescriber in complying with the policies and procedures of the Community Program for Opioid 45 Pharmacotherapies, the ability of the prescriber to maintain appropriate levels of client care for managing more than 150 clients, available support services and any other information considered to be relevant. In exceptional circumstances authority may be provided by the Chief Executive Officer for an approved prescriber to temporarily exceed their maximum patient numbers in order to ensure continuation of care for existing patients. In the event of concerns emerging about public amenity due to a large number of clients attending a particular medical centre or general practice, the matter may be considered by the CPOP Management Committee which may recommend changes to the maximum number of clients who can be treated at the service. Patient numbers per approved pharmacy The maximum number of clients to whom pharmacies are authorised to dispense as part of the program is the equivalent of 50 clients per day. To exceed this number a pharmacy may apply in writing to the Pharmaceutical Services Branch of the Department of Health. The Department of Health will forward the application to the CPOP Management Committee for consideration. Following a review of the pharmacy to determine capacity to manage more patients, the CPOP Management Committee will make a recommendation to the Chief Executive Officer to increase the pharmacy’s patient numbers. In assessing the application consideration of the record of the pharmacy in complying with the policies and procedures of the Community Program for Opioid Pharmacotherapy, the ability of the pharmacy to maintain appropriate levels of client care for managing more than 50 clients and any other information considered to be relevant. In the event of concerns emerging about public amenity due to a large number of clients attending a particular pharmacy, the matter may be considered by the Professional Review Group who may recommend changes to the maximum number of clients. Maximum dose Approval must be obtained from the Department of Health to prescribe above a dose of 120 mg of methadone or 24 mg of buprenorphine. An ‘Application for Authority to Prescribe Pharmacotherapy in Excess of the CPOP Policy for an Opioid Dependent Person’ form is to be completed and sent to the Clinical Advisory Service (CAS) for endorsement prior to forwarding to the Department of Health. If approved an authorisation is issued by the Department of Health. Takeaway doses policy Authorised prescribers must comply with the schedule of takeaway doses of methadone and buprenorphine as set out in the ‘Takeaway Policy’ (See below). This schedule has been developed to balance the benefits of providing takeaway doses with the serious potential for misuse and the risks this presents. Approval must be obtained from the Clinical Advisory Service (CAS) to prescribe more than the number of takeaways set out in the schedule or to prescribe takeaway doses of Subutex ®. An ‘Application for Authority to Prescribe Takeaway Doses for an Opioid Dependent Person’ form should be completed and sent to the Clinical Advisory Service (CAS) for consideration and endorsement. Prescriptions A patient participating in the CPOP should only be prescribed one dose (excluding split doses) of methadone or buprenorphine per day. In order to reduce the potential for dosing at multiple sites to occur, when multiple prescriptions are written for a patient, the authorised prescriber 46 must ensure that the additional prescriptions do not authorise additional doses to be obtained from another pharmacy on the same day. Renewal of authority to prescribe The Department of Health will forward to the prescriber an ‘Application for Renewal of an Authorisation to Prescribe Methadone/Buprenorphine for an Opioid Dependent Person’ form during the month prior to expiration of a patient’s authorisation. The prescriber must renew the authority by completing the form and returning it to the Department. Patients under the age of 18 years Methadone is only registered for use in patients aged 18 or over. Buprenorphine has been registered for administration to people aged 16 and over. Caution should be exercised in prescribing a drug of dependence for anyone under 18 years of age. However, positive results have been reported from the combination of buprenorphine with behavioural interventions for the treatment of opioid-dependent adolescents. Potential medico-legal implications of prescribing methadone or buprenorphine outside of the product information should be considered. Patients under 18 years of age must be referred to Next Step Youth Service for a comprehensive, multi-disciplinary assessment. Applications for authority to prescribe for patients under 16 years of age will require special approval from the Chief Executive Officer. Next Step Youth Service is able to instigate treatment and stabilise the patient before referring them back to the prescriber. Next Step Youth Services are also able to offer ongoing consultation for medical practitioners treating young patients. In cases where the prescriber, for reason of their location in a remote area, cannot access Next Step Youth Services the Clinical Advisory Service should be contacted to discuss alternative assessment options. Schedule for takeaway doses First six months* of treatment Except in exceptional circumstances no takeaway doses of methadone or buprenorphine should be prescribed until the patient has been in continuous treatment for six months. Wherever possible the patients should be placed with a seven day pharmacy to enable daily dosing. Alternatively a second dispensing point may be used on the seventh day if the patient attends a six day pharmacy. Methadone Length of time in treatment * Number of takeaway does permitted 6–12 months After six months of continuous treatment and where the patient is assessed as stable and is working towards achieving treatment goals, they may be eligible for one takeaway dose of methadone per week. 12–24 months After 12 months of continuous treatment and where the patient has demonstrated stability with one takeaway does per week they may be eligible for two non-consecutive takeaway doses per week. 47 Length of time in treatment * Number of takeaway does permitted More than 24 months After two years of continuous treatment and where the patient has demonstrated stability with two takeaway doses per week they may be eligible for three takeaway doses of methadone per week. Only two of these may be consecutive. Buprenorphine (Suboxone®) Buprenorphine has a long half life (24–36 Hours) and many patients can be dosed every second or third day thus minimizing the need for takeaway doses. The long half life of buprenorphine can also mean that takeaway doses are more easily diverted as missing part or all of a day’s dose does not result in severe opiate withdrawal. For this reason no more than one takeaway dose per week is permitted for patients prescribed buprenorphine until they have been on the program for 24 months. Length of time in treatment * Daily dosing Dosing every second day Dosing every third day Less than 6 months Limited to exceptional circumstances 6–24 months 1 per week 1 per week More than 24 months 2 per week 1 per week *Note: duration refers to continuous period of dosing with either methadone or buprenorphine. It does not refer to continuity with the same service provider. Size of the takeaway doses The takeaway dose must not exceed the normal supervised daily dose. Safety of takeaway doses The takeaway dose(s) must be given to the patient on the day before the scheduled day(s) of absence from the usual dispensing location. Patients are responsible for the care and proper consumption of each takeaway dose once they have taken possession of it. To avoid risk of consumption by children or other unauthorised people the patient should be advised that takeaway doses should be stored in a place that is not easily accessible by people other than themselves. Each takeaway dose should be supplied in a separate container with a child-resistant closure and carrying the label ‘Keep out of reach of children’. To further reduce the risk of overdose by children it should not be necessary to refrigerate takeaway doses of methadone. Each takeaway dose of methadone should be diluted in 100 mL of water. There should be labelling warning of the possible associated hazards when driving or operating machinery. Other labelling and preparation requirements should be fulfilled in accordance with the regulations of the Poisons Act 1964. To maintain safety standards and proof of ownership, patients should be advised not to transfer takeaway doses to containers without the appropriate labels. Takeaway doses of buprenorphine do not need to be crushed. 48 Appendix 2. Health Districts by postcode Area Health Service NMAHS SMAHS WACHS Health district Postcode Oceanic ≥6000 and ≤6017 Stirling SEC ≥6021 and ≤6022, 6050, 6052, ≥6059 and ≤6061 Joondalup ≥6023 and ≤6028 Wanneroo ≥6030 and ≤6038, ≥6064 and ≤6065 BayswaterBassendean ≥6051 and ≤6054, Valley and Hills ≥6055 and ≤6056, 6063, ≥6061 and ≤6074, 6076, ≥6081 and ≤6090, 6500 Kalamunda ≥6057 and ≤6058, 6076 Stirling Coastal ≥36018 and ≤6020, 6029 Armadale ≥6108 and ≤6126, ≥6201 and ≤6206 Bentley ≥6100 and ≤6107, ≥6147 and ≤6148, ≥6151 and ≤6152 Fremantle ≥6149 and ≤6150, ≥6153 and ≤6164, 6166 Peel ≥6207 and ≤6215 Rockingham Kwinana 6165, ≥6167 and ≤6176 Blackwood 6244, ≥6254 and ≤6256 Bunbury ≥6229 and ≤6231, 6237, ≥6271 and ≤6275 Busselton ≥6280 and ≤6282 Central Great Southern ≥6316 and ≤6320, ≥6335 and ≤6336, ≥6341 and ≤6343, ≥6394 and ≤6395 East Pilbara ≥6721 and ≤6724, 6753, ≥6758 and ≤6762 Eastern Wheatbelt ≥6368 and ≤6369, ≥6385 and ≤6386, ≥6410 and ≤6428, ≥6472 and ≤6473, ≥6476 and ≤6484, ≥6487 and ≤6490 Gascoyne 6537, ≥6701 and ≤6707 Geraldton ≥6528 and ≤6532 49 Area Health Service WACHS Health district Postcode Kimberley ≥6725 and ≤6743, ≥6765 and ≤6770 Leeuwin ≥6284 and ≤6290 Leschenaults ≥6218 and ≤6224, ≥6226 and ≤6228, ≥6232 and ≤6236 Lower Great Southern ≥6321 and ≤6333, ≥6337 and ≤6338, ≥6396 and ≤6397 Midwest ≥6514 and ≤6515, ≥6517 and ≤6519, ≥6522 and ≤6525, ≥6535 and ≤6536, ≥6614 and ≤6632 Murchison 6439, ≥6635 and ≤6642 Northern Goldfields ≥6429 and ≤6438, ≥6440 and ≤6442, 6444 South East Coastal ≥6346 and ≤6348, 6343, ≥6445 and ≤6450 ≥6306 and ≤6315, ≥6350 and ≤6367, ≥6370 Southern Wheatbelt and ≤6375, ≥6390 and ≤6393, 6452 Warren ≥6258 and <=6262, 6398 Wellington 6225, ≥6239 and ≤6243, ≥6251 and ≤6253 West Pilbara ≥6710 and ≤6720, ≥6751 and ≤6752, 6754 Western Wheatbelt ≥6041 and ≤6044, ≥6302 and ≤6304, ≥6380 and ≤6384, ≥6401 and ≤6409, ≥6460 and ≤6471, 6475, 6485, ≥6501 and ≤6513, 6521, ≥6560 and ≤6613 Patients were assigned to an Area Health Service (AHS) and Health District based on the postcode of the address listed on the application form. Postcodes were allocated to an AHS and Health District based on information provided by the Epidemiology Branch of the Department of Health. 50 Appendix 3. Projected populations per Health District for adults in 2012 Area Health Service Health district Population ≥18 Bayswater-Bassendean 60,619 Joondalup 124,922 Kalamunda 43,695 Oceanic 114,989 Stirling Coastal 56,957 Stirling SEC 100,664 Valley and Hills 113,882 Wanneroo 112,571 Armadale 141,667 Bentley 156,006 Fremantle 184,846 Peel 78,387 Rockingham-Kwinana 104,690 Blackwood 5,597 Bunbury 36,850 Busselton 24,148 Central Great Southern 8,111 East Pilbara 16,339 Eastern Wheatbelt 10,325 Gascoyne 8,696 Geraldton 27,535 Kimberley 31,318 Leeuwin 10,719 Leschenaults 26,281 Lower Great Southern 38,636 Midwest 11,276 Murchison 3,559 NMAHS SMAHS WACHS 51 Area Health Service WACHS Health district Population ≥18 Northern Goldfields 31,487 South East Coastal 13,728 Southern Wheatbelt 14,402 Warren 7,934 Wellington 11,308 West Pilbara 16,804 Western Wheatbelt 26,296 Total 1,775,244 Population denominators for 2012 The average age was 35.8 years for Subutex®, 38 years for Suboxone® and 39.8 years for methadone, were provided by the Epidemiology Branch of the Department of Health via Rates Calculator Version 9.5.4 (Jim Codde, 1993–2005) and are estimated projections from data obtained from the Australian Bureau of Statistics (ABS) Series B. 52 Appendix 4. Map of approved CPOP prescribers and dosing sites in the Perth metropolitan area 53 This document can be made available in alternative formats on request for a person with a disability. © Department of Health 2012