Drugs of Dependence Unit Telephone Facsimile Issued: 13 July 2010 Updated: 1 February 2012

Transcription

1 Drugs of Dependence Unit Telephone Facsimile Issued: 13 July 2010 Updated: 1 February 2012 Guidelines for action to be taken in response to serious breaches of the drug treatment programs - Opioid Dependence Substitution Programs [ODSP] and Suboxone Opioid Substitution Programs [SOSP] 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, and may be varied by prescribers as necessary. However, the Unit may amend a section 18A authority to enforce the public policy reasons behind these guidelines. Opioid pharmacotherapy programs carry substantial risks to patients and people patients may interact with. Serious breaches also place the program itself at risk should health professionals and the community withdraw their support and involvement. Besides, breaches may result in tightening of general rules that create personal hardship for the majority of responsible patients that benefit from the pharmacotherapy programs. Consistent application of these guidelines helps support the integrity of the program. Patients should be aware of the consequences of serious breaches and are entitled to expect a reasonably consistent response from prescribers, pharmacists and the Drugs of Dependence Unit. Scope of these guidelines Serious breaches cover behaviours that are incompatible with ongoing treatment with a drug of dependence via the drug treatment programs ODSP & SOSP. These include suspected or confirmed diversion of the methadone/buprenorphine (+/-naloxone) dose, unlawful alterations to prescriptions, and trafficking in drugs or other substances. Diversion Diversion of the dose includes not consuming the dose to the complete satisfaction of the dispensing pharmacist or other person responsible for dosing supervision. Pharmacists may require the patient to drink some fluid, converse after dose administration, or allow oral inspection 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. Patients are required to consume their medication methadone/buprenorphine (+/-naloxone) as prescribed by the medical practitioner. 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 and the Drugs of Dependence Unit. The attached incident report form can be used. The prescriber should contact the Drugs of Dependence Unit so the circumstances and the proposed consequences can be discussed.

2 Drugs of Dependence Unit, Medicines and Technology Policy and Programs Page 2 A. Suspected Attempted Diversion 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 suspension of up to two (2) days 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 ongoing take-away privileges, it is suggested that no take-away privileges be permitted for a period of at least six months. 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 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. Injection or smoking of unsupervised doses should be treated as confirmed diversion. 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 suspension of up to two (2) days 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 may be obtained from Drug & Alcohol Advisory Clinical Service ( ) 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 If treatment is to continue, no take-away privileges permitted for a period of at least six months. Alternate day supervised dosing with buprenorphine with naloxone (Suboxone ) tablet/film may be an option. Buprenorphine with naloxone (Suboxone ) tablet/film may be easier to divert but it may be less attractive illicitly, safer with misuse, and permits easier withdrawal if a breach is repeated. Where the patient is maintained via the Suboxone Opioid Substitution Program consideration should be given to referring the patient for review at DASSA clinical services or by accredited Opioid Dependence Substitution Program prescriber. 5) For repeated incidences of diversion, consideration should be given to termination of treatment program a) If breach is considered to be very serious, treatment should be immediately terminated and symptomatic treatment of withdrawal symptoms may be offered, b) If breach is considered not to be very serious, treatment should be terminated after a rapid withdrawal program involving i) Dispensing transferred to a seven day pharmacy with significant experience managing complex clients ii) iii) No take-away privileges provided and 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.

3 Drugs of Dependence Unit, Medicines and Technology Policy and Programs Page 3 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, c) the patient should not be considered for readmission to a program for a minimum period of three months from the date treatment is terminated and d) if readmitted, no take-away privilege for at least six months or as the Section 18A authority specifies. 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 confirmed diversion. Fraudulent changes to the prescription are required to be reported to the Commissioner of Police. Failure to secure unsupervised doses Consideration should be given to removing all unsupervised dosing privileges due to the gravity of this and the risks to children, other adults and animals. 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 should not be tolerated. Threatening or unacceptable behaviour should be addressed by the practitioner inline with agencies such as South Australia Police (Ph 000 for urgent attendance and Ph for non-urgent attendance), relevant Occupational Health, Safety and Welfare legislation and policies, and established patient contracts which refer to acceptable behaviour and continuation of treatment between the patient and pharmacy, patient and medical practitioner/surgery. General In applying these guidelines, consideration should be given to any special needs of the patient. Patients who are pregnant or terminally ill may need special consideration. Patients in rural or remote areas may have limited options. In these cases it is recommended the prescriber and/or pharmacists discusses the situation with the Drugs of Dependence Unit. Drugs of Dependence Unit staff may refuse to authorise any treatment that presents an unacceptable health risk to individuals or the wider community. Colin Brown, Manager, Drugs of Dependence Unit

4 Drugs of Dependence Unit Telephone Facsimile INCIDENT REPORT FOR SERIOUS BREACHES OF DRUG TREATMENT PROGRAMS [Opioid Dependence Substitution Programs [ODSP] and Suboxone Opioid Substitution Programs [SOSP] This report should be completed where a serious breach of a drug 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 film tablet 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 ) YES NO DRUG DEPENDENCE UNIT (Ph ) 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 DRUGS OF DEPENDENCE UNIT (Fax No )

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