GUIDELINES FOR ACTION TO BE TAKEN IN RESPONSE TO SERIOUS BREACHES by lindash

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									Drug Policies & Programs                                                             Telephone 1300 652 584
Drugs of Dependence Unit                                                             Facsimile 1300 658 447
Issued: 23rd January 2006                        www.dassa.sa.gov.au (health professionals, legal controls)




        GUIDELINES FOR ACTION TO BE TAKEN IN RESPONSE
      TO SERIOUS BREACHES OF DRUG TREATMENT PROGRAMS


These guidelines are issued to assist prescribers, pharmacists and other health care workers working in
drug treatment programs to handle serious breaches. These are guidelines only, compliance is not
mandatory and consideration should to be given to any extenuating circumstances in individual cases.
They may be varied or not complied with when necessary. Health care workers within the Prison Health
Service will have separate guidelines due to their particular circumstances

Opioid Dependence Treatment programs carry substantial risks to patients and people patients may
interact with. Serious breaches also place the program itself at risk in local areas as health professionals
and the community may withdraw their support or it may result in a tightening of general rules that create
personal hardship for the majority of responsible patients that benefit from the program.

Patients should be aware of the consequences of serious breaches and expect a reasonably consistent
response from prescribers, pharmacists and the regulators. A uniform approach has demonstrated a
reduction in unacceptable behaviour in various clinics.


SCOPE OF THESE GUIDELINES

Serious breaches cover behaviours that are incompatible with ongoing treatment. These include
suspected or confirmed diversion of the methadone/buprenorphine dose, continuing to traffic in drugs
and perceived intimidating, violent or threatening behaviour by the patient.


DIVERSION

Diversion of the dose includes not consuming the dose to the complete satisfaction of the pharmacist or
other person responsible for dosing supervision. Pharmacists may require the patient to drink some fluid
and converse after dose administration to be satisfied the dose has been consumed. Diversion also
includes the supply or permitting the supply of a take-away dose of the drug to another person, for
whatever reason.

The consequences of diversion can be serious and may result in the serious injury or death of the patient
or another person. It may also result in health professionals withdrawing their support and participation
in the program and thus affecting other patients, or unfavourable scrutiny by the Coroner, policy makers
and the public. Other jurisdictions have taken drastic action in response to diversion including the
cessation of non-supervised doses.

In all cases of suspected diversion or attempted diversion, the pharmacist should report the incident to the
prescriber. The prescriber should advise the Drugs of Dependence Unit of the circumstances.
SA Drugs of Dependence Unit                     SERIOUS BREACHES OF OPIOD DEPENDENCE TREATRMENT PROGRAM
Page 2

A. Suspected Attempted Diversion or Minor Abusive Behaviour

First infringement. Where diversion is suspected or attempted diversion has occurred for the first time, it
is recommended that the following actions be taken:
     1) Immediate three day suspension of dosing,
     2) All take-away privileges (if any) are terminated until treatment can be reviewed by the
         prescriber.
     3) Prescribers should review the patient’s stability and review on-going take-away privileges,
     4) Prescribers warn patients of the consequences of a repeated infringement.
     5) The dispensing pharmacist may review their willingness to continue to service that patient and
     6) The incident is reported to the Drugs of Dependence Unit. The attached incident report form can
         be used

Repeat infringements. For repeated episodes of suspected or attempted diversion, the episode may be
treated as an episode of confirmed diversion.


B. Confirmed Diversion, Repeated Suspected Diversion or Moderate to Severe Abusive Behaviour
    .
    Where the prescriber or pharmacist forms the opinion that they are certain or it is highly probable
    diversion has occurred, the following actions should be taken.

    1) The incident should be reported as soon as practical to the Drugs of Dependence Unit and to
       the prescriber (if applicable) preferably by facsimile, The attached incident report form can be
       used

    2) Immediate three day suspension of dosing. The pharmacist should contact the prescriber and
       obtain directions before any further doses are provided. Where the prescriber is not contactable,
       interim advice can be obtained from Drug & Alcohol Advisory Service (1300 131 340) or Drugs
       of Dependence Unit.

    3) The prescriber should review treatment as soon as practical and determine if treatment goals are
       being achieved and if treatment should continue.

     4) For a first transgression of diversion or moderate abusive behaviour
        If treatment is to continue, no take-away privileges permitted for a period of at least six months.
        Alternate day supervised dosing with buprenorphine may be an option.
        Buprenorphine may be easier to divert but is less attractive illicitly, safer with misuse and
        permits easier withdrawal if offence is repeated.

     5) For repeated incidences of diversion or significant abusive or violent behaviour,
        consideration should be given to termination of treatment program

         a) If offence is considered to be very serious, treatment should be immediately terminated
            (e.g. assault of health worker) and symptomatic treatment of withdrawal symptoms may be
            offered,

         b) If offence is considered not to be very serious, treatment should be terminated after a
            rapid withdrawal program involving
            i) Dispensing transferred to the Midnight Pharmacy (if near Adelaide),
            ii) No take away privileges provided and
            iii) Rapid withdrawal to be initiated.
                 1) For methadone:
                      • Doses above 100mg methadone per day – reduction by 20mg each week, then
                      • Doses above 30mg and up to 100mg per day – reduction by 10mg each week, then
                      • Doses of 30mg and below per day – reduction by 5mg each week to zero.
                 2) For buprenorphine,
                      • Doses above 12mg buprenorphine per day – reduction by 4mg each week, then
                      • Doses of 12mg and below per day – reduction by 2mg each week to zero.
            iv) If an additional suspected diversion or a confirmed diversion incident occurs during this
                 withdrawal phase, ongoing dosing should be terminated immediately and, symptomatic
                 treatment offered if appropriate,
SA Drugs of Dependence Unit                          SERIOUS BREACHES OF OPIOD DEPENDENCE TREATRMENT PROGRAM
Page 3

          c) the patient should not be considered for readmission to a program for a period of three
             months from the date treatment is terminated and

          d) if readmitted after three months, no take-away privileges for at least six months.
                   Alternate day supervised dosing with buprenorphine may be an option. Buprenorphine
                   may be easier to divert but is less attractive illicitly, safer with misuse and permits easier
                   withdrawal if offence is repeated.


PRESCRIPTION TAMPERING AND FORGERY ETC

Fraudulent changes to the prescriptions, such as change of dose, change in the number of takeaways or
impersonating the prescriber to change prescribed dispensing arrangements, is a serious breach of trust
and should be treated as for suspected diversion. Fraudulent changes to the prescription are required to
be reported to the Commissioner of Police by s.30 of the Controlled Substances Act 1984.


THREATENING, VIOLENT AND OTHER UNACCEPTABLE BEHAVIOUR

Perceived intimidating, threatening or violent behaviour to the prescriber, surgery staff, the pharmacist,
pharmacy staff or other patients or customers is not be tolerated. Threatening behaviour includes
patients contacting or approaching prescribers or pharmacists out of the business environment, such as
contacting them at or attending their personal residence.
Unacceptable behaviour includes verbal abuse, property damage, theft from the pharmacy, drug dealing
and demands for take-away doses before they are due.

As the degree of this behaviour may vary, so should the response.
1)      Minor breaches may result in a warning to the patient and/ or transferring treatment to another
        prescriber or dispenser.
        The prescriber or pharmacist should consider if they wish to continue to be involved with the
        ongoing treatment of the patient after an incident,
2)      Moderate breaches should be treated in the same manner as confirmed diversion, and.
3)      Major breaches should result in immediate cessation of treatment.
        Patients may be offered some symptomatic treatment for withdrawal symptoms or may consult
        Warinilla for a possible detoxification program.

4)        Moderate and major breaches should be reported to this Unit. This is necessary as the
          patient may present for treatment at another prescriber or seek treatment in the near future. ,
          The attached incident report form can be used
          Options for future treatment may include authorising treatment with the prescriber and dispenser
          warned of the risks, treatment may be limited to Warinilla where there is additional security for
          clinical staff.


GENERAL

In applying these guidelines, consideration should be given to any special needs of the patient. Patients
who are pregnant or terminally ill may be given special consideration. Patients in regional areas may
have limited options. In these cases it is recommended the prescriber or pharmacists discusses the
situation with the Drugs of Dependence Unit.

The Minister responsible may refuse to authorise any treatment if there remains an unacceptable risk to
the personal safety of clinic staff, dispensing staff, other patients or the community.



Geoff Anderson, Manager,
DRUGS OF DEPENDENCE UNIT T
ODTP SERIOUS BREACHES 0406.doc ..DOC
INCIDENT REPORT FOR SERIOUS BREACHES OF DRUG TREATMENT PROGRAMS
This report should be completed where a serious breach of the Opioid Dependence Treatment Program occurs
Reporting incidences will ensure a more appropriate treatment plan for the patient and a more satisfactory outcome
for health care workers involved in these programs.

PERSON MAKING REPORT………………………………………………………… DATE OF REPORT ………………..

ADDRESS ……………………………………………………………………….………………………………………………

CONTACT DETAILS …………………………………………………………………………………………………………

IF PHARMACY, PHARMACY NAME ………………………………………………………………………………………

PATIENTS NAME …………………………………………………………………… DATE OF BIRTH …………………..

CURRENT ADDRESS ………………………………………………………………………………….……………………..

DRUG TREATMENT                             METHADONE              DOSE………….mg/ day
                                           BUPRENORPHINE          DOSE…………. mg/ day/alternate day
                                           BUPRENORPHINE/NALOXONE DOSE…………. mg/ day/alternate day
                                           OTHER

DATE OF INCIDENT …………..……..…………….                   TIME OF INCIDENT …………………………………………...

BRIEF EXPLANATION OF INCIDENT …………………………………………………………………..………………….

………………………………………………………………………………………………………………………………..….

…………………………………………………………………………………………………………………………..……….

…………………………………………………………………………………………………………………………………...

…………………………………………………………………………………………………………………………………….

DO YOU CONSIDER THIS BREACH                         MINOR
                                                    MODERATE
                                                    MAJOR

IF THIS INCIDENT HAS PRECIPITATED AN OUTCOME, WERE YOU SATISFIED WITH IT                           YES
                                                                                                   NO

IF NOT SATISFACTORY, WAS ADVICE SOUGHT FROM THE
               DRUG AND ALCOHOL ADVISORY SERVICE (Ph 1300 131 340)                              YES
                                                                                                NO
                 DRUG DEPENDENCE UNIT (Ph 1300 652 584)                                                  YES
                                                                                                NO

COMMENTS REGARDING OUTCOME ….………………………………………………………………………………….

……………………………………………………………………………………………………………………………………

……………………………………………………………………………………………………………………………………

…………………………………………………………………………………………………………………………………….

IF REPORT MADE BY A PHARMACIST, HAS THE AUTHORISED PRESCRIBER BEEN CONTACTED                             YES
                                                                                                         NO

PLEASE FAX THIS REPORT TO THE FOLLOWING
              THE DRUG DEPENDENCE UNIT (Fax No 1300 658 447)
              IF A DASSA PATIENT, THE COMMUNITY PHARMACY COORDINATOR (Fax No 8130 7575)
              IF THE PHARMACIST IS REPORTING THE INCIDENT, TO THE PATIENT’S PRESCRIBER

								
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