The film was not a drama Peter Muhleisen. This study Phase IV study QI project across HNE district...
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Transcript of The film was not a drama Peter Muhleisen. This study Phase IV study QI project across HNE district...
The film was not a drama
Peter Muhleisen
This study
• Phase IV study• QI project across HNE district• Investigators: Adrian Dunlop, Peter Muhleisen, Lyn
Gardner, Julie Carnell, Amanda Brown, Cathy Cochrane
• Based on Evaluation of suboxone film implementation in drug and alcohol settings – Lintzeris N, Leung S, Paige E
• Describes change of medication • Compares client experience• Compares clinic flow data
Competing interests
• This study was investigator-led and funded as a clinical quality improvement project by Hunter New England LHD.
• Adrian Dunlop and Peter Muhleisen have received honoraria and travel support from Reckitt Benckiser for presenting at professional educational forums and conferences.
• Reckitt Benckiser had no role in the study design, data collection, analysis, interpretation of data or publication of findings for this study.
Was there a problem?
The drug buprenorphine (BPN)• Has street value and a history of misuse• Tablets are easier to divert than methadone. • Dose supervision is more time consuming than methadone • Relatively few BPN clients can cause a service delay• Delays increase incidence of aggression and stress for
service users and staff.• Much BPN supervision was inadequate• The supervision process
– is demeaning for patients and – unhelpful in building a therapeutic alliance.
BNX SL Film (Suboxone)
• Introduced 2011• Equivalent to BNX SL tablets• Potential benefits:
– Reduced supervision time– Reduced potential for diversion– Increased convenience– Increased efficiency for dosing points
• Potential harms– Clients leaving treatment– Increased harms from injection
Hunter New England Local Health District
• 900 clients in opioid substitution treatment• Almost 200 clients are dosed at 3 clinics,
– Newcastle >100, – Cessnock and Taree ~30-50 each
• Total numbers in buprenorphine treatment around 200 in the district
• >75% clients dose at community pharmacies• Reviewed 3 monthly minimum
Methods
• Clients were offered transfer to film at scheduled program reviews from September 2011 to April 2012
• Voluntary participation in this study• No inducements• Questionnaired pre transfer (or refusal) and• At next scheduled review in 3 months• About 22% participation
Transfer for clients dosing at NPS
All Buprenorphine dosing at NPS clinic
23
10
10 00
2
6
8
11
15
18
21
14
11
56
2
00
5
10
15
20
25
Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12
Month
Pati
en
ts BPN Mono
BNX Film
BNX Tab
Cessnock (all prescribed BPN clients)
Cessnock all Buprenorphine
0
10
20
30
40
50
60
Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12
BPN
BNX T
BNX F
Study Participants at entry
• Newcastle• 14 clients in study, all from BNX tablets•
Cessnock• 22 clients, from 17 BNX tablets, 4 BPN tablets, 1 MTD
• Tamworth• 4 clients, from 3 BNX tablet, 1 BPN tab• Taree• 6 clients all from BNX tablets
ATOP drug use at entry(compared to historical control BNX day 84 2009)
% client days used /month
0
10
20
30
40
50
60
70
80
90
100
Heroin Other Op Alcohol THC Amphet Cocaine BZD Tobacco
Drug
day84BNX
EntryBFI
Client perception of previous treatment
• Visual analog scale of 100 mm
• Ease taking dose Av 76.2 (± 23.9)• Taste Av 35.3 (± 26.8)• Satisfaction Av 75.8 (± 27.1)
Clients’ feeling about change
• Extremely happy 11 28.2%• Somewhat happy 13 33.3%• Indifferent 10 25.6%• Somewhat unhappy 3 7.7%• Extremely unhappy 2 5.1%• N=39, 1 did not answer, 6 did not change
Reasons given• Save time 70%• Takeaway access 40% • Taste 65%
Reasons to not transfer
• Won’t hold 3/6• Happy now 4/6
Dose adequacy/change needed
0%20%40%60%80%
100%
1 2
1 Adequacy 2 Change
Much too low
Slightly low/go up
Adequate?same
Slightly HIGH/go down
Time at dose point
Time at dose pointprev tx
0-5min20%
6 to 10 min37%
11 to 15 min25%
16 to 20 min13%
>20 min5%
Supervision time
Supervision time prev tx
No4%
1 min5%
2-3 min14%
4-5min62%
6 to 10 min11%
11 to 15 min2%
16 to 20 min2%
No
1 min
2-3 min
4-5min
6 to 10 min
11 to 15 min
16 to 20 min
Post transfer data
• 15 of 22 clients at Cessnock PS transferred to film and completed second questionnaire
• 6 clients transferred from BNX tablets to film at Taree, less happy to change than at Cessnock
Drug use before and after change to film n =21
% client days of drug use per month
0
5
10
15
20
25
30
35
40
45
50
BNX tab
BNX film
Health & Quality of Life n =21
Health and QOL
56789
10
PSYCHHEALTH
PHYSHEALTH
QOL
Sc
ore
(ou
t o
f 1
0) MeanPRE
MeanPOST
Side effects n=21
Side effects pre and post
0 10 20 30 40 50 60 70 80 90 100
ANXIETY
BONE/JOINT PAIN
CONSTIPATION
DRY MOUTH
EXCESSIVE SWEATING
HEADACHES
INCREASED APPETITE
TROUBLE SLEEPING
ITCHY SKIN
LACK OF ENERGY
POOR APPETITE
REDUCED LIBIDO
TROUBLE THINKING
Sy
mp
tom
% of subjects% pos POST
% pos PRE
χ2 analysis No sig differences p > 0.17
Client appreciation of drug n=21
Client appreciation
0
20
40
60
80
100
EASE TAKING DOSE TASTE OF DOSE SATISFACTION
Lik
aert
sco
re (
of
100)
MeanPRE
MeanPOST
Client feeling about change (pre and post) n =21
Happiness to change (pre)
24%
24%28%
14%
10%
Extremely happy
Somewhat happy
Indifferent
somewhat unhappy
extremely unhappy
Client feeling about change (post)
53%
14%
33%
Extremely happy
Somew hat happy
Indifferent
Time taken in the clinic and dosing n = 21
Time at clinic and supervision time
0
2
4
6
8
10
12
14
16
18
Time at clinic Supervision
Min
ute
sMeanPRE
MeanPOST
Treatment outcomes (Sep 2012) n =42
• 37/42 remain in treatment, • 34 at the clinic. • Of the 36 who transferred to film voluntarily 30 remained in treatment.• 1 transfer to MTD, 1 returned to tablets, 1 to GP still in tx, 1 dropped out, 1
completed withdrawal
• Of 6 clients that did not wish to change two were incarcerated one involuntary transfer to film and one dropped out of treatment. One client still in BNX tablet treatment, 1 remained in Methadone treatment.
• Overall 88% remain in tx, 83% of those transferred still in film treatment
Newcastle Clinic flow : average 93 doses per day
Clinic flow by time of day
0
2
4
6
8
10
12
14
16
18
8.01-8.30
8.31-9.00
9.01-9.30
9.31-10.00
10.01-10.30
10.31-11.00
11.01-11.30
11.31-12.00
Time of day
Cli
ents
do
sed
Cli
ents
wai
tin
g
Ave BPN
Ave MTD
WR Oct 2011
WR post ave 2012
Time taken to dose
• Calculated from drug register entries• * statistically significant
Month BNX tablets BNX film
October 2011 3m 45 s( ±2m)
January 2012 4m 16s (±1m 29s)*
3m 40s (±2m 06)
April 2012 3m 06s (±1m 44s)*
Time to Dose cumulative % of clients
Time Taken to Dose Cumulative % of clients on Methadone (MTD), BNX tablets and BNX film
0
10
20
30
40
50
60
70
80
90
100
< 1 min 1 min 2 min 3 min 4 min 5 min 6 min 7 min
Time taken to dose
Cu
mu
lati
ve %
cli
en
ts d
osed
% BNX tabs Jan
% MTD Jan
% MTD Oct
% BNX Film Apr
Evidence of harm
• 2 reports of injecting by clients not currently in treatment (1 with neck abscess)
• One report of acquisition by a client unable to attend• Report by staff member of sachets being seen in public place• 3-5 reports of attempted diversion of film*• Reports of BPN diversion reduced from 1.8 inc/month in 2011
to 0.6 inc/month, of which over half are still tablets• No reports back from other clients of mouth diversion• Reports that “quite a process to prepare for injection”• 1 report of sublingual blisters ( on 15/11/12) to investigate
Conclusions
• Transfer easily managed as part of regular program reviews Use of film • Slightly reduced dosing time, • Slight increase in clinic flow • Reduced inadequate supervision of BPN dosingClients reported • increased satisfaction with film dosing, • film dosing was slightly quicker and • 67% were happy with the change• none unhappyThese clients remained stable in treatment, little evidence of negative consequences.
Slight changes likely to be more significant in pooled data
The film was not..
• A drama• A farce• A tragedy• A horror movie• A western ( no cowboys yet)• An epic• And IT SO COULD HAVE BEEN!
Off you go! …
– ( as we can now say to our BMT patients)• Nothing to see here..
Credits• Cathy Cochrane Julie Carnell, Amanda Brown,
Rose Gray, Lyn Gardner