The Tasmanian Response to its Prescription Drug Problems ...

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The Tasmanian Response to its Prescription Drug Problems ...

Tasmania’s s Response to its

Prescription Drug Problems

Medicine in Addiction Conference

18­20 March 2011

Citiclub Hotel, Melbourne

Dr Adrian Reynolds

Clinical Director

Alcohol & Drug Services

DHHS, Tasmania


Tasmania’s s Problems Began Early

• Tasmania does not have a heroin market

• It has a significant prescription opioid problem that began in the early

1990s when long acting oral opioid formulations became available

• Applications for authority to prescribe S8 drugs have ballooned from

2500 in 2004‐05 to >7,000 in 2009‐10

– Dubious honour of tussling with NT for highest rates of prescribing

& related problems

• Substantial morbidity & mortality


Morphine‐g/1000 population


Oxycodone‐ g/1000 population


Methadone 10mg tabs per 1000 population


Higher than National Prescribing of Alprazolam


Intra‐arterial arterial Injection Alprazolam


‘Rapidly

progressive

necrotizing

fasciitis’ from

injecting

Suboxone

requiring

amputation of

whole arm


Tasmania Opioid Related Deaths 2004­2009

2009


Average age of Deaths Associated with Opioids


Sharpened Minds

• This is what sharpens our minds clinically

• This is why those of us who think carefully about what we are

seeing over & over & who use our capacity for inductive &

deductive reasoning, take the Hippocratic Oath seriously

to help or at least do no harm


Sharpened Minds

• In response to comments made at the conference yesterday, let me

stress that no lawyer or Ombudsman can tell any doctor to provide

unsafe treatment or to practice what the doctor knows to be ‘bad

medicine’

• Any patient seeking a legal remedy to obtain drugs of a nature, in

quantities & in ways that on careful assessment & based on evidence

& collective medical experience, amounts to bad medicine, will not

hold sway on my watch


At Least Do No Harm

• Quite extraordinary that some doctors are being intimidated & ‘bullied’ by

lawyers to prescribe S8 & S4 drugs to patients demonstrating aberrant

behaviour & high risk

– After doctor initially said ‘no’ for good reason & declined to prescribe

• I will hand the stethoscope to the lawyer & walk away from Medicine

before I agree to or wittingly collude with requests or expectations

that I support clinical practices that are unsafe & unsound


Preparing Doctors to Manage Pain

& Addiction


We Have Not Adequately Prepared Our

Doctors

• Doctors have found themselves at front line of ATOD & pain

problems, rarely well prepared by their medical training

• Evident that many doctors are struggling with the challenges of

knowing:

– How to assess & manage pain, particularly in the face of a

history of AOD problems & related maladaptive behaviours …


We Have Not Adequately Prepared Our

Doctors

– Doctors don’t in general appear to have a good command of

the evidence in relation to persistent non malignant pain

(PNMP) & its multi‐modal clinical management

• Because we haven’t adequately trained & prepared them in the

undergraduate & post‐graduate settings


We Have Not Adequately Prepared Our

Doctors

– This often translates to inappropriate & problematic prescribing in

the face of often inadequate & inaccurate clinical assessment

• Leading too often to unrealistic expectations (‘zero pain’, 24

hours a day), poor pain management, drug focused thinking &

chemical coping, chronic pain syndrome, opioid dependence &

a range of aberrant behaviours (‘yellow’ & ‘red’ flags)


We Have Not Adequately Prepared Other

Health Professionals

– Other health professionals (nurses, social workers, psychologists

etc.) have similarly not been well prepared in their training to

detect, accurately assess & appropriately contribute to the clinical

management of PNMP, AOD problems as they emerge &/or related

maladaptive behaviours


We Have Not Adequately Prepared Other

Health Professionals

They may also develop unrealistic & unhelpful expectations of

what the doctor should do (e.g. keep increasing the opioid dose

when already high doses are not working or asking , even

pressuring doctors to allow take away doses when they are not

themselves adequately or accurately assessing clinical or public

risk)


Tasmania Decides to Act

• In the presence of clear & significant harm associated with

prescription drugs & in the absence of guiding action in other

Australian jurisdictions, Tasmania went on the front foot in 2007


Strong Support from Above was Key

The CEO SSS (DHHS) (as it was called then), Dr John Crawshaw & senior

officers of the ADS gained strong support from the Minister for Health

• Undertook strategic planning leading to the Future Services Directions

Plan that was fully funded by the Minister for Health

– Strong support from other senior officers in the Department

– CHO a champion of the ATOD sector

• Significant enhancements to the ATOD sector has been achieved in

Tasmania with more to come ( & more to do)


What has Tasmania Done to

Address its Prescription Drug

Problem?


Tasmania Taking The Initiative

The RACP Prescription Opioid Policy (2009) lays out a rational

framework for addressing the prescription drug problem in

Australia

• While other AUS jurisdictions are seemingly in the ‘contemplation’

phase (‘there will be no political support for this report’ or ‘let’s

watch and see’), Tasmania had already moved on many of its

recommendations, among other responses


RACP Prescription Opioid Policy (2009)

1. National expert advisory group to develop a coordinated

approach to improve the management of CNMP & to reduce the

unsanctioned use of pharmaceutical drugs

2. Develop a set of guidelines that are primarily appropriate & useful

for general practice

3. Enhance clinical practice particularly at the primary health care

interface

4. Improve information systems (real time reporting)

5. Regulation & control

6. Minimising unmet demand for opioid substitution therapy

7. Training & research

- We moved on all strategies in green


Drugs & Poisons Regulatory Leadership

• Led by the Chief Pharmacist (Mary Sharpe), our PSB has proved

itself to be a drugs & poisons regulatory agency that is clinically

astute, proactive, responsive & effectual in promoting &

supporting the QUMs & public safety

• Willing to lead


Regulatory Reform

The PSB brought on a number of amendments to the Poisons Act &

Regulations after consulting with the RACGP, RANZCP & ADS, e.g.

• Alprazolam which is a declared restricted substance under the

Tasmanian Poisons Act (S4D), was added to the required monthly

reporting of dispensed schedule 8 substances from Tasmanian

pharmacies & prescribing in a patient also prescribed opioid

medication, requires an authority to do so


Expert Advisory Panel


Expert Advisory Panel

• RACP Rec. 1: Established an Expert Advisory Panel compromising Pain

Medicine & Addiction Medicine specialists, a representative of the Division

of GP & pharmacists to assist the Chief Pharmacist assess GP requests for

authority to prescribe S8 drugs in the face of clinical complexity & concern

– Exceedingly thorough process of clinical review of most complex

cases

– Still refining processes: next phase is to assist GPs utilise Universal

Precautions (including continuous assessment based on 4A+2A+1As) as

routine framework for all S8 authority applications

• Will act as learning prompt & we anticipate lead to better care & better clinical

outcomes


Framework for Assessment


Consent Points


Refined Decision Making Processes

• Developed decision making algorithms to guide S8 authority

application processing

The Pain Management Unit at the RHH brought Dr. Roger Goucke

(Pain Medicine specialist in Perth) to Tasmania to work with our

pain medicine specialists, the Div of GP, GPTT, PSB, ADS & other

key players to develop prescribing guidelines for GPs & ED doctors


1. Protocol for

Opioid

Prescribing in

Tasmania

developed to

assist GPs


2. Protocol for

Opioid

Prescribing in

Tasmania

developed to

assist GPs


Quick

Reference

Guide for

Doctors

seeking

authority to

prescribe S8

drugs &

alprazolam


Process for

assessment of

application for

authorisation

to prescribe

under S. 59E


Guideline for

prescribing

opioids in

emergency

settings


Joint Pain & Addiction Medicine Mx

• Pain & Addiction Medicine specialists in Tasmania are actively

planning & working together to develop new systems & agreed

pathways for assessing & facilitating multi‐modal, multidisciplinary

pain management ...e.g.

– Pain Group led by Palliative Care physician

– Increasingly frequent clinical case conferencing b/n Pain & AM clinicians

& sharing & discussion of research literature


Joint Pain & Addiction Medicine Mx

– Cross training & joint U/G & P/G medical training

– Review of discharge planning processes to ensure there is a clear pain

management plan that includes adequate pain relief & clear

instructions for managing any opioid medication that is provided on

discharge (dose taper, for how many days before ceasing, how many

tablets to be dispensed)


Working With GPs

• RACP Rec. 3: Addiction Medicine & Pain Medicine specialists have

begun working as a team with the Divisions of GP & GPs to provide a

mix of interactive teaching as well as complex case discussions around

pain & addiction

– Also beefing up our consultation liaison services to GPs & teaching

hospitals & beginning to work closely with Pain Medicine colleagues

–treating each consult as a rich teaching opportunity


Preventing Chronic Pain Syndrome

• RACP Rec 3: A new & innovative Liaison Pain Management service

has been established at the RHH aimed at intervening early when

there are signs that acute pain may transition to a chronic pain

syndrome or where other opportunities for early intervention can be

identified

– Will assist GPs & will we anticipate, reduce their burden of

complex cases that so often have less than best possible clinical

outcomes


Growing the Specialist Workforce

• We are encouraging medical students to consider & doctors to

enter the fields of Addiction Medicine & Pain Medicine

– Concerned that at present, jurisdictions do not appear to be

setting aside specific funds to support registrar training

positions in both areas of medical specialty

– Puzzling because …


Pain & Addiction Medicine Specialists in Very

Short Supply

– We have only a tad over one Pain Medicine specialists per

80,000 population & less than one Addiction Medicine

specialist per 120,000 population actively practicing at

present in Australia at present

• So specialist assessment & treatment of patients as well as

teaching & support of GPs presents many challenges

– Clear & significant disconnect between health burden,

need & medical specialist training in these two areas

» Why is this so?


Real Time Reporting


Real Time Reporting in Tasmania

• RACP Rec. 4: Every pharmacy in Tasmania (now >90%) will soon be linked

into a statewide real time reporting system, with all dispensing of S8 drugs

& alprazolam coming real time into PSB

– Now rolling out the next phase which is the DORA (Drugs and Poisons

Information System Online Remote Access) feedback loop of this clinical

information system, to provide this real time information to all doctors in the

community & in hospitals in Tasmania

– Final phase is a roll out to all pharmacies in Tasmania (Q3 in 2011)

• Much more comprehensive & clinically meaningful system than Project STOP


Real Time Reporting in Tasmania

• So all doctors in Tasmania will soon have access to this key clinical

information on S8 medications & alprazolam dispensed to patients at

point of clinical contact

– With a mouse click they will be able to see what scripts have been

prescribed & dispensed & when, whether another doctor has been

issued with an authority to prescribe, any alerts, their own

authorities to prescribe, etc...

• This will facilitate better clinical decision making & risk management


National Real Time Reporting

• Growing consensus in support of RACP policy statement that we must

as a matter of priority, implement national real time reporting that is

linked into each jurisdiction’s regulatory agency & that is actively

managed by appropriately skilled regulators & clinicians working

together to examine & make decisions about the most complex cases


National Real Time Reporting

• National registration of doctors & the high risks associated with cross

border prescribing/ dispensing (prescription drug tourism) has suddenly

rendered this an even more urgent & important task

• I would ask for your active support for NRTR & advocacy communicated

clearly & strongly through senior levels of government in your

jurisdiction


Privacy Issues

• High level legal advice has been provided on Privacy issues &

found not to present a barrier to RTR in Tasmania

– Commonwealth Privacy Act 1988

Tasmanian Personal Information Protection Act 2004

• I hear many people expressing unfounded & unhelpful beliefs &

values in relation to this matter


RTR in Tasmania


DORA PRESCRIBER HOME

Displays number of patient authority applications and patient authorities grouped by status.


DORA MY AUTHORITIES

My Authorities populates a list of the patient authorities issued to the prescriber that is

currently logged in.


National Real Time Reporting

• Money is now available from the Commonwealth government

under the Fifth Community Pharmacy Agreement to develop a

national RTR & the Commonwealth has commenced exploring

the possibilities with the States & Territories


Linking Regulatory to Clinical

The States & Territories will however need to invest in the

development of much more robust mechanisms for linking

regulatory & clinical expertise in order to monitor & actively

manage the prescribing of analgesic & psychotropic drugs

• Though even having RTR information available to the prescribing doctor &

dispensing pharmacist (as a first step) will enable & facilitate better clinical

decision making at the clinical coal face


Grasping the Public Policy Ball

• Unfettered prescribing in the face of risk or harm (yellow & red flags)

is not in the patient’s or anyone else's best interest

• We agree with the RACP that monitoring the dispensing of S8 drugs &

issuing authorities to prescribe S8 medications, is critical as one

among a range of responses for improving clinical & public health &

safety outcomes associated with prescribing S8 drugs


Building Clinical & Regulatory Capacity

• RACP Rec. 5: Tasmania has a governance structure, size & mix of

technical expertise & resourcing of its drugs & poisons regulatory body

that enables it to monitor S8 medications & alprazolam & fulfill its

responsibilities under the Poisons Act & Regulations

• Key Questions:

– Are other D&P bodies across the nation similarly able to do so?

– Do they possess strong working linkages to Pain & Addiction Medicine specialists &

do they engage this clinical expertise in regulatory decision making in a way that

promotes the QUM?

– If the answer is not a resounding ‘yes’, why is this so & what is required to remedy

this malady?


Dropping The Public Policy Ball*

– Public policy nihilism is apparent, though unintended I am sure,

among some senior personnel in the ATOD sector & this is difficult to

understand in the context of a prescription drug problem that is

rapidly getting away from us across the nation

• Note the observations of Dr Mike McDonough, Dr. Malcolm Dobbin &Dr Nick

Lintzeris in this regard & what has already occurred in the USA & Canada

• Worrisomely, I hear some policy DMs are arguing there is no evidence the

downsizing of their jurisdictional response has made things worse


Grasping the Public Policy Ball*

• But they can’t know this if they are not monitoring or not monitoring &

communicating with clinicians in a comprehensive, effective & timely

manner ... in effect, regulators & policy decision makers, can’t know

what they don’t know

• Nor can doctors have a full appreciation of the risks & harms

associated with loose jurisdictional regulatory responses & with their

own clinical practices when they have no timely access to all of the

information they require to make valid & reliable judgments about the

safety & appropriateness of their own & their colleagues prescribing


Principle of Equity of Access To Healthcare

• RACP Rec. 6: Our Medicare & PBS systems are designed fundamentally

on the basis of the principle of ensuring cost effective utilisation of

medicines & equity of access to health care for all Australians, without

blame for behaviours that may harm health

These principles are important not only for there intrinsic value reflecting a

beneficent society, they are also supported by a very robust evidence base

demonstrating the clear relationship between equity, values of beneficence

& health outcomes


OST on PBS

– Treatment must be affordable & accessible

– As one element of the Fifth Community Pharmacy Agreement, the

Commonwealth government recently put a proposition to States &

Territories in relation to ‘staged supply’ of certain medications but

excluded OST from these arrangements

• If staged supply is not seen as appropriate for OST, Tasmania will

continue pursuing support to place it on the PBS & including it in

the safety net

– Including a fair dispensing fee for pharmacists


Placing OST on PBS & Safety Net

• Tasmania* has taken a paper arguing the case through IGCD/

MCDS (2007 ‐ 09) & have been advised to re‐direct it through

AHMAC to the AHMC (soon to become the ‘Standing Council on

Health’)

• We will be looking to all jurisdictions to provide clear & strong

support for Tasmania in this important public health endeavour

at the next meeting of AHMAC at end of June 2011

– It is simply too costly for us to continue ignoring this health policy

error


Placing OST on PBS & Safety Net


We Need Good Public Policy

• Will be difficult for Commonwealth government to continue to exclude

people who need & who can benefit from this treatment, from

accessing it on the same basis as any other citizen who is able to access

other necessary pharmaceuticals under PBS

– Particularly when this treatment is inexpensive by any economic

metric (esp. when compared to medications like the newer

generation anti‐psychotics) & particularly when we know it works & it

that it is cost‐effective

• Among a range of arguments, the present cost is a serious barrier to

moving patients with PNMP who develop a drug problem, across to OST


Research & Teaching

• RACP Rec 7: Tasmania is paying increased attention to teaching at

undergraduate & post‐graduate levels in the areas of addiction & pain

medicine but there is a pressing need for an agreed & carefully

structured national curriculum as well as innovative methods of

teaching & supporting clinical behavioural change

• AM & PM specialists are now working closely with the UTAS Medical School &

Division of GP to move on this challenge in Tasmania


Research & Teaching

• ADS in Tasmania does no presently have any research capacity

– Nor does the Pain Medicine sector

• So many clinical questions that need answering in the clinical

management of PNMP including in patients with emerging or established

opioid addiction

• We agree on the importance of developing this capacity & identifying the

most important research questions to pursue research in this underdeveloped

but important area of health care

– Why do we pay such little attention to funding & supporting research in this area?


Tasmanian Opioid Review

• Why is Tasmania seeing so many problems related to the

prescribing of opioid medications & other drugs of

dependence, particularly in the context of aberrant

behaviours & addiction?

• Tasmania decided to undertake its own broad ranging review

of opioid prescribing (& of other drugs of concern) & pain

medicine


T.O.R. for the Tasmanian Opioid Review

• To conduct a staged review which will develop prioritised

recommendations and a implementation plan in relation to ‘evidenceinformed’

prescribing of opioid medication for:

– Pain management, generally

– Pain management, specifically in the context of drug addiction or risk of

addiction

– Safe prescribing, of Schedule 8 opioids and other drugs of dependence, in

a manner that takes into account patient & community safety & the

requirements of best practice chronic pain medicine & addiction medicine


Prescribing Review Will Further Assist

• We are looking to our Opioid Review to make recommendations

about a range of other more specific reforms in our systems & how

we can better respond to this serious & challenging set of human

problems

• To improve health outcomes through the quality use of medicines &

to reduce risk & harm

The National Pharmaceutical Drugs Misuse Strategy being led by

Victoria will also inform these processes


Disconnect between Health Burden &

Australia’s s Response


ATOD Sector Has Top Billing?

• A whopping 13% of our national burden of disease is attributable to

the use of ATODs –about the same as for mental health problems ‐

yet only 0.33% of our national health budget was spent of drug &

alcohol treatment in 2002/03 (Moore, 2005)

• Compare this with a much larger 8% of our national health budget (25

times the ATOD treatment budget) that is presently spent on Mental

Health (AIHW, 2009)

• Why is this so? It makes no sense....


Burden of Disease & Risk factors


Good ATOD Policy Requires Strong

Leadership

• This is where the medical profession sits on the normal curve in

relation to its intellectual & academic capacity


Good ATOD Policy Requires Strong

Leadership

• This where the medical profession sits in terms of the leadership it is

presently providing in Australian society in relation to public policy on

alcohol, tobacco & other drugs

– And in Australian society more generally...

Why are we not

speaking up &

making a more

substantial

contribution?


Good Governance Requires Good People to

Stand Tall

• Victoria’s counter‐evidential & highly harmful deregulated liquor

licensing laws were mentioned here yesterday (though not much

better in other jurisdictions)

– A very good illustration of the medical profession missing from action in the

1990s through to now!

• We have gone to sleep in the ATOD sector


NDS Fails to Take us Forward

• NDS (2010‐2015) endorsed by the final formal MCDS held last month, is

exceedingly disappointing

– Focuses on politically easy, low lying fruit that will make little difference to public

health (e.g. no mention of tightening the structural controls on alcohol or

volumetric taxation, no mention of building the size & technical capacity of the

ATOD sector (clinical, policy & planning) commensurate with the very substantial

burden of harm & need for more effectual responses....)

– Fails to build on evidence & lessons learned & fails to take us forward as a nation

– Sends a clear message that ATOD problems are not important & that despite

claims to the contrary, we don't care as a society...not really!


NDS Fails to Take us Forward

• I advised senior officers in Tasmania that as the State’s Clinical

Director, I could not responsibly endorse the draft NDS prior to its

presentation to MCDS last month


NDS Fails to Take us Forward

• Where is the medical profession...& the medical Colleges & other

august bodies ...& Police for that matter...in all of this?

• Where are we in relation to our very serious alcohol problem &

standing up to the alcohol industry that demonstrates selfish disregard

for the health & well being of the youth of Australia & indeed, the

broader population

• Our unified voice would be a voice to reckon with


Good Governance Requires Good People

to Stand Tall

• We need to awaken, find leaders who can more clearly,

confidently & with scientific & moral authority communicate the

evidence, hold the likes of Big Booze to account & build real

capacity within the ATOD sector

• What say you ladies & gentlemen?

• Who among you is up to this challenge?


THANK YOU

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