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Canberra Hospital and Health ServicesClinical Guideline Alprazolam – Prescription and Management of Referrals (MHJHADS)Contents

Contents....................................................................................................................................1

Guideline Statement.................................................................................................................2

Scope........................................................................................................................................ 4

Section 1 – Alprazolam prescribing...........................................................................................4

Section 2 – Managing referrals from GPs for Alprazolam prescription.....................................5

Implementation........................................................................................................................ 6

Related Policies, Procedures, Guidelines and Legislation.........................................................6

References................................................................................................................................ 6

Search Terms............................................................................................................................ 7

Attachments..............................................................................................................................7

Attachment 1 – Alprazolam letter to GP...............................................................................8

Attachment 2 – Alprazolam Letter to Person Referred.......................................................10

Attachment 3 – Flow chart for managing referrals for Alprazolam.....................................12

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Guideline Statement

BackgroundAlprazolam is a high potency, short acting anxiolytic of the benzodiazepine class that was reclassified as a Controlled Medicine in February 2015.

The Therapeutic Goods Administration (TGA) made the decision to reschedule Alprazolam from Schedule 4 to Schedule 8 under the Commonwealth Standards or Uniform Scheduling of Medicines and Poisons (SUSMP) after advice from the Advisory Committee on Medicines Scheduling following extensive public consultation.

The reasons for the change in schedule for Alprazolam included: Alprazolam has increased morbidity and mortality in overdose with possible increased

toxicity. It does not appear to have any additional therapeutic benefits compared with any other

substance in its class. There has also been a rapid increase in use of Alprazolam compared with other

benzodiazepines and evidence of widespread misuse. Concerns about increased toxicity. Concern that the current pack size is inappropriate for indications. There is evidence of abuse of the substance and misuse with opioids. Listing in Schedule 8 of Alprazolam does not restrict its short-term use for the approved

indication.

Alprazolam can cause significant physical dependence even when used as prescribed, with a range of adverse effects and life-threatening withdrawal symptoms.

Alprazolam AbuseThe high potency, rapid onset of action and euphoric effects of Alprazolam make it a preferred substance of abuse and is the most commonly abused benzodiazepine amongst Australian injecting drug users. It is subject to greater extra-medical or illicit use than medical use, and causes a disproportionately higher level of harm than other benzodiazepines. Potential harms associated with Alprazolam abuse including ischemic limb damage and disability associated with injecting Alprazolam; acute amnesic periods which can last for days; disinhibited and aggressive behaviour, and overdose and death when used concurrently with opioids.

Risky behaviours whilst under the influence are common including driving, assaults, other drug use, criminal behaviour and waking from a period of amnesia in a frightened and distressed state.

Increased prescribing of Alprazolam has been documented in recent years as well as an increase in Alprazolam related deaths. Following rescheduling and tighter parameters for prescribing, these numbers have begun to decline.

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The ACT Controlled Medicines Prescribing Standards (the Prescribing Standards) requires a General Practitioners (GP) wishing to seek prescribing approval to prescribe alprazolam from the Chief Health Officer to have documented support from a psychiatrist that clearly supports the use of Alprazolam accompanying an application.

In addition, the Pharmaceutical Benefits Scheme (PBS) will now only subsidise Alprazolam for the treatment of panic disorder, with a number of limitations. The PBS will not subsidise treatment of chronic anxiety.

However, it is noted that a number of people treated by General Practitioners have been prescribed Alprazolam over the long term and for conditions that require psychiatrist support under the Prescribing Standards. This means that referrals for Alprazolam prescription are now being received by Adult Community Mental Health Teams with the expectation of reviewing people for suitability and if necessary provide support for ongoing GP prescribing of Alprazolam.

It is the recommendation of the Australian Medical Association (AMA) and supported by MHJHADS that in most cases Alprazolam is not indicated as an ongoing treatment, and most people will be transferred to another benzodiazepine and referred back to the GP for continuing management. However, it is noted that for some people in very limited circumstances, a clinical decision for treatment with Alprazolam can be justified.

The National Prescribing Service (NPS) recommends that benzodiazepines, including Alprazolam, are not recommended as first line treatment for anxiety or panic disorder.

The NPS fact sheet Anxiety disorders – which treatment for what anxiety disorder? can be found on the NPS website.

A summary of the Royal Australian and New Zealand College of Psychiatrists (RANZCP) clinical practice guidelines for the treatment of panic disorder and agoraphobia are available on the RANZCP website.

The Royal Australian College of General Practitioners (RACGP) has issued a health alert on rescheduling of Alprazolam to a Schedule 8 poison, to provide GP’s with some management strategies when a person requests a prescription for Alprazolam, and can be found on the RACGP website.

Key Objective To provide Adult Community Mental Health Teams and prescribing Psychiatrists within

MHJHADS with a framework for managing referrals from GPs for review for suitability and if necessary support ongoing treatment with Alprazolam.

To provide Psychiatrists with current prescribing information and strategies to assist GPs in ceasing Alprazolam prescriptions.

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Scope

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This clinical guideline pertains to medical and clinical staff within MHJHADS under the clinical governance of the Chief Health Officer (CHO) and the Chief Psychiatrist. It applies to all areas within MHJHADS and refers to both adults and children.

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Section 1 – Alprazolam prescribing

Alert: Changes to prescribingAlprazolam is a Controlled Medicines listed in Schedule 8 of the SUSMP.

Under the Prescribing Standards, Psychiatrists or Addiction Specialists may apply for a Category 4A prescribing approval from the Chief Health Officer for treatment of Panic Disorder or short-term symptomatic treatment of anxiety with Alprazolam.

A prescriber (other than a psychiatrist) who wants to prescribe Alprazolam must provide an application to the Chief Health Officer by drug. The application must be accompanied by documented support from an appropriate specialist (that is, a psychiatrist) that clearly supports the requested dosing regimen and indication.

Alprazolam is no longer subsidised by the PBS in 2mg preparations.

Alprazolam is only authorised for Panic Disorder and short term symptomatic treatment of Anxiety with the following criteria: The treatment must be for use when other treatments have failed; OR The treatment must be for use when other treatments are inappropriate and Where Panic Disorder is not attributed to some known organic factor.

Alprazolam is no longer subsidised under the Pharmaceutical Benefits Scheme (PBS) for the treatment of anxiety or related disorders Furthermore, the available quantity of units has been reduced from 50 tablets down to 10 tablets with no increase in the maximum number of repeats.

Alprazolam should only be prescribed when a clear diagnosis of Panic Disorder has been made and where other non-pharmacological, non-benzodiazepine and other benzodiazepine treatments have failed or are inappropriate; and there is no comorbid alcohol or substance use disorder or polydrug use. Further noting that Panic Disorder is a fairly uncommon illness, statistically affecting 2-3 percent of adults.

Short term prescription of Alprazolam (under two months) is permitted without authority for the treatment of anxiety under the short term approvals for non-drug dependent people.

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As per the ACT Health Controlled Medicines Prescribing Standards, psychiatrists can seek CHO approval for Alprazolam under CATEGORY 4A, that being a controlled medicine to treat a person with a licensed indication.

The Psychiatrist is treating a person with panic disorder or short term symptomatic treatment of anxiety (that is, a licensed Australian Register of Therapeutic Goods (ARTG) indication) with Alprazolam up to 10mg daily under this category.

The CHO further recommends that a person has biannual psychiatric reviews with the aim to discontinue Alprazolam.

The CHO may ask for further information when considering the application for Alprazolam approval, including but not limited to seeking evidence of specialist support.

As per the Controlled Medicines Prescribing Standards, prescribers are advised that Alprazolam (Category 4A) application is NOT available for: a prescriber other that a psychiatrist to prescribe Alprazolam for a licensed ARTG

indication; a Psychiatrist to prescribe Alprazolam at dosages higher that 10mg daily; or treating an indication not listed on the ARTG.

In these circumstances the prescriber must apply for controlled medicine approval by drug. The CHO can issue a controlled medicine approval by drug for up to 12 months.

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Section 2 – Managing referrals from GPs for Alprazolam prescription

Following the introduction of the Controlled Medicines Prescribing Standards, GP now require support from a psychiatrist to in order to apply to prescribe Alprazolam. This means that people within the primary care sector will likely be referred into MHJHADS by their GP for review and support if necessary for ongoing Alprazolam treatment by a Psychiatrist.

It is the goal of the organisation to reduce and cease Alprazolam prescription where possible and support GPs to switch people on to an alternative benzodiazepine or taper down and cease the Alprazolam all together.

Following receipt of a referral from a GP for Alprazolam prescription, the relevant Community Mental Health Team should send the attached letter back to the GP (See Attachment 1) and the further attached letter to the person (See Attachment 2).

The letter to the GP provides a description of the organisations goals around Alprazolam cessation as well as providing further management strategies for the person whilst awaiting their appointment. The letter should be sent by the duty officer to the GP upon receipt of referral and an outpatient appointment made.

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Appointments for Alprazolam opinion are not considered urgent.The letter to the person provides information to inform them prior to their appointment of the organisations goals to cease Alprazolam. This is to ensure that when the person arrives for their appointment, they do not attend with the expectation of ongoing Alprazolam prescription.

The person should be contacted prior to the scheduled appointment to confirm their attendance.

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Implementation

The contents of this guideline will be communicated throughout the Adult Community Mental Health Teams and other relevant teams where applicable through the provision of leadership and governance meetings.

GPs will be notified of the referral changes through the MH GP Liaison Nurse and the GP Liaison Unit at the Canberra Hospital.

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Related Policies, Procedures, Guidelines and Legislation

Policies Canberra Hospital & Health Services - Medication handling policy

Guidelines ACT Health - Controlled Medicines Prescribing Standards

Legislation Medicines, Poisons and Therapeutic Goods Regulation 2008 Medicine, Poisons and Therapeutic Goods Act 2008 Mental Health Act 2015 Poisons Standard February 2017 Human Rights Act 2004

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References

1. Australian Government: Department of Health, Therapeutic Goods Administration. Standard for the Uniform Scheduling of Medicines and Poisons. February 2017 from https://www.tga.gov.au/publication/poisons-standard-susmp

2. Darke S, Torok M & Duflou J. Circumstances and toxicology of sudden or unnatural deaths involving Alprazolam. Drug and Alcohol Dependence 2014. 138. 61–66.

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3. Rintoul AC; Dobbin MDH; Nielsen S; Degenhardt L; Drummer OH, Recent increase in detection of Alprazolam in Victorian heroin-related deaths. Medical Journal of Australia 2013. vol. 198, pp. 206 - 209, 10.5694/mja12.10986

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Search Terms

Alprazolam, Xanax, Referral, Mental Health, Justice Health & Alcohol and Drug Services, GP

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Attachments

Attachment 1 – Alprazolam letter to GPAttachment 2 – Alprazolam Letter to Person ReferredAttachment 3 – Flow chart for managing referrals for Alprazolam

Disclaimer: This document has been developed by Health Directorate, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

(to be completed by the HCID Policy Team)Date Amended Section Amended Approved ByEg: 17 August 2014 Section 1 ED/CHHSPC Chair

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Attachment 1 – Alprazolam letter to GP

     [Insert date]

Dear Dr      [Insert GP name] of doctor

Re:       [Insert persons name and DOB]

Thank you for your referral for an opinion regarding the suitability for ongoing prescriptions of Alprazolam.

As you will be aware, Alprazolam is a Schedule 8 drug with the requirement to apply to the Chief Health Officer (CHO) for approval to prescribe. Under the Controlled Medicines Prescribing Standards, GPs are required to have specialist support when applying for CHO approval to prescribe Alprazolam from a psychiatrist. Additionally the PBS restricts the subsidy of Alprazolam to Panic Disorder where other treatments have either failed or are inappropriate.

Evidence based guidelines recommend treatments including other medications and psychological therapies for anxiety disorders rather than Alprazolam.

Useful references: RANZCP guidelines for treatment of anxiety disorders: https://www.ranzcp.org/Files/Resources/Publications/CPG/Clinician/CPG_Clinician-Full_Panic_Disorder_Agoraphobia-pdf.aspx

NICE guidelines for Generalised Anxiety disorder and panic disorder in adults: https://www.nice.org.uk/guidance/cg113

Controlled Medications Prescribing Standards: http://health.act.gov.au/sites/default/files//Medicines%20and%20Poisons%20-%20Controlled%20Medicines%20-%20Prescribing%20Standards_1.pdf

You may wish to transition your patient onto a longer acting benzodiazepine, such as Diazepam, as an interim measure, particularly if they are on a high dose of Alprazolam. Generally speaking around 5mg of diazepam is roughly equivalent to 0.25mg of Alprazolam. This can vary between individuals and so the dose may need to be adjusted and the person should be reviewed frequently. This switch may also be useful if the patient agrees to a graduated downward taper with the goal of cessation of benzodiazepine use.

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Generally speaking, for people who have been on benzodiazepines long term, the dose can be reduced by approximately 10% per week, however again this may vary between individuals. The long term prescription of benzodiazepines is generally not recommended.

It is our expectation that if Alprazolam is prescribed the ongoing prescribing and monitoring of this medication will be undertaken by the patient’s General Practitioner. If you are unable to do this please let us know and assist the patient to find a General Practitioner to fulfil this role.

We can offer biannual reviews of this medication with the therapeutic goal of discontinuing this medication, as recommended by the Controlled Medications Prescribing Standards. We are also able to provide specialist review and opinion concerning the management of anxiety disorders or other psychiatric disorders.

It would assist us if you were able to provide some additional information concerning the patient:

This includes: How long you have known the patient. Rationale for treatment with Alprazolam and duration of treatment. Evidence of Alprazolam dependence or misuse such as escalating doses or asking for

scripts early. History of drug or alcohol dependence Current medical history. Specifically history of falls, cognitive impairment, liver disease

or pregnancy. Current medications and doses. History of psychiatric illness including self harm or suicide attempts. Patient’s occupation – particularly whether they drive or operate heavy machinery for a

living or are involved in shift work or any other form of work or recreation where prescription of a sedating medication potentially poses a risk to themselves or others.

Please also ensure you let us know should the patient’s contact details change.The referral will progress once we receive the information above.Of course you are welcome to contact us for further information or clarification concerning the service we provide.

Kind regards,

[Insert Psychiatrist name]     

[Provide a contact detail for the GP to discuss further if required]     

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Attachment 2 – Alprazolam Letter to Person Referred

[Insert date]     

Dear [Insert person’s name]      

You have been referred to [Insert clinic name]       for an opinion regarding your medication Alprazolam (also known as Xanax, Kalma or Alprax).

You have an appointment scheduled with Dr [insert Dr name]       at [insert date/time/location]      .

As you may be aware there were some changes to the law around the prescribing of this medication. It was changed to a different category of medication and some additional restrictions were placed around it, specifically that a specialist opinion was required for ongoing prescription. The reasons for this were concerns around harm associated with this medication. There are concerns that Alprazolam use can lead to addiction and a number of adverse outcomes which can be discussed with your GP.

Having an appointment with a Psychiatrist is not a guarantee that Alprazolam will be prescribed. For some people, the Psychiatrist may recommend alternative treatments to Alprazolam and give your General Practitioner (GP) advice on how best to provide these. Expert guidelines on the treatment of anxiety disorders recommend against the use of Alprazolam in most cases and recommend other treatment options including some that don’t involve medication.

The possibility of changes to medication can understandably lead to people feeling worried. Please discuss any concerns that you may have about this with your GP or the psychiatrist that you see. Please be assured that we will endeavour to give you the best possible evidence based care.

There are a large number of people needing Psychiatrist appointments through our service. If you cannot attend your appointment please let us know as soon as possible so we may offer the appointment to someone else. If you cancel your appointment with less than two business days notice or miss it altogether without letting us know, it may be some time before the next available appointment.

Please contact us on [Insert clinic phone]       to confirm your attendance at this appointment, if you need to change your appointment time or if you require any further information in regard to this referral.

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Kind regards,

     [Insert Clinician name]

     [Provide a contact detail for the GP to discuss further if required]

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Attachment 3 – Flow chart for managing referrals for Alprazolam

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The Adult Community Mental Health Team recieves an Alprazolam related referral

from a GP

The Duty Officer (DO) determines if the referral is complete. If not, a request for further referral information is sent to the

GP

The DO sends out the Alprazolam GP letter and the Alprazolam patient letter

The DO requests the administrative officer to schedule an outpatient appointment

The admin officer schedules an appointment and sends a notification to the

GP and to the patient

The admin officer confirms the patients attendance to the appointment 1 - 2 weeks

prior