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