OTP Flashcards

Question

Buprenorphine: drug interactions

Answer 1

``` Increased sedative effects through additive CNS depression, respiratory depression or increased plasma levels resulting from decreased metabolism or urinary clearance Amitriptyline Atazanavir Benzodiazepines Fluvoxamine Zopiclone ``` Withdrawal symptoms or adverse effects may cause decreased plasma levels and withdrawal symptoms due to increased metabolism or other mechanisms Ritabutin Ketozonazole Prolongation of QT interval may be contraindicated in combination due to further QTc prolongation Domperidone Effects on other medication may impact adversely on medications used in combination Other opioids (may block therapeutic effect due to higher affinity, may precipitate withdrawals)

Answer 2

If buprenorphine is given too soon after a dose of an opioid, it may precipitate withdrawal symptoms; buprenorphine displaces other opioids from receptor sites, but because it has low activity, it may have mild opioid effects, which may not be sufficient to prevent withdrawal. Buprenorphine-precipitated withdrawal is usually mild-to-moderate in severity, and may require symptomatic treatment (in which case, seek specialist advice); it begins within 1–4 hours of the first dose and lasts for 2-5 days There is an increased risk of precipitated withdrawal when transferring from long-acting opioids, eg controlled release products, methadone.

Answer 3

1. Delay first buprenorphine dose until patient in early opioid withdrawal 2. Withhold at least 6-12 hours after short acting opioid (e.g. heroin, morphine, codeine) and up to 24 hours after long-acting opioid (e.g. methadone) 3. 4mg test dose if patient in mild opioid withdrawal 8mg test dose if patient in moderate-severe opioid withdrawal 4. If seeing patient in the community, ask them to return to clinic to re-dose if required. Recommended time between doses would be at minimum one hour 5. Titrate dose on following days 6. Increase by 2, 4 or 8 mg per day as required Reach target dose by day 3 - usually aim for 8-24mg per day`

Answer 4

Individually titrate dose to achieve treatment goals (stop use of other opioids, manage pain, prevent withdrawal) Most patients need 12 to 24mg (max 32mg) buprenorphine daily

Answer 5

Safety of buprenorphine allows for alternate day & ; 3-day dosing for patients not suitable for take-away doses, or where access may be limited (rural and remote Queensland) Can be initiated once buprenorphine dose stable Alternate (2) day dosing = 2 x daily dose (to max 32 mg) Three day dosing = 3 x daily dose (to max 32 mg) Not all patients stabilise on 2 or 3 day dosing Increased withdrawal, cravings &; poor sleep on non-dosing days in about one third of patients Offers additional choice for patients

Answer 6

Prescription Opioid Transfer Information Initiate treatment as per ‘heroin user’ Do not use opioid dose equivalence conversion tables as often difficult to estimate actual doses of pharmaceutical opioids consumed Neither methadone nor buprenorphine readily convert to opioid equivalent dose 1. Transferring from Methadone to buprenorphine Main concern is precipitated withdrawal Buprenorphine has higher affinity but lower activity at opioid receptors than methadone In patient who has recently used methadone, buprenorphine may precipitate withdrawal as it displaces full agonists Seek specialist support if transferring from moderate-high dose methadone (>40 mg)

Answer 7

Mechanism of action: combination of opioid agonism and N-methyl-d-aspartate (NMDA) antagonism producing a dependence forming analgesic response and building opioid tolerance (blocking effects of other opioids > 60 - 80mg thereby harder to overdose or buy enough heroin to work on top). Absorption: readily absorbed after oral administration with high oral bioavailability ~ 80%. Distribution: Peak plasma concentration reported 1-5 hours after dose, though onset much quicker at ~1 hour after dose. Metabolism: Hepatic metabolism CYP3A4 being the main enzyme, however 2D6, 2B6, and 1A2 (if tobacco being used). Elimination: half-lives vary considerably (15-60 hours being reported) and careful adjustment is necessary with repeated administration. Accumulation over time with a steady state reached at around 5 days, thus greatest risk of mortality is in the first 2 weeks of commencing therapy. Urinary and faecal excretion occurs with some metabolites unchanged.

Answer 8

Methadone Syrup® – also contains contains sorbitole, glycerol, ethanol, caramel, flavouring and sodium benzoate Biodone Forte® - also contains permicol-red colouring Both solutions contain 5mg/1ml and the written instruction should always be recorded as mg/ml to avoid confusion or incorrect dosing.

Answer 9

Increased sedative effects The medications in this group may increase the risk of overdose through additive CNS depression, or increased plasma levels of methadone resulting from decreased metabolism or decreased urinary clearance Amitriptyline Benzodiazepines (alprazolam, diazepam, triazolam) Ciproflaxin Citalopram/escitalopram Erythromycin Fluconazole Fluoxetine Fluvoxamine Indinavir Ketoconazole Moclobemide Ompeprazole Ritonavir (avoid using in combination with atazanavir) Sertraline Urine alkalisers (e.g. sodium bicarbonate) Zopiclone Withdrawal symptoms or adverse effects The medications in this group may cause decreased plasma levels and withdrawal symptoms due to increased metabolism of methadone or may cause adverse effects through other mechanisms Carbamazepine Cimetidine Disulfiram (if used in conjunction with methadone formulations containing alcohol) Hypericum perforatum (St John’s Wort) Moclobemide Nevirapine Phenytoin Rifampicin Rifabutin Urine acidifiers (e.g. ascorbic acid) Ketoconazole Prolongation of QTc interval These medications may be contraindicated by the manufacturer for use in combination with methadone due to their capacity to cause prolongation of the QTc interval Domperidone Citalopram/escitalopram Erythromycin Thioridazine Effects on other medications Methadone may also impact adversely on the other medications that may be used in combination Atazanavir (methadone may decrease serum levels) Desipramine (metabolism decreased leading to increased plasma levels of desipramine) Nifedipine (metabolism may inhibit methadone) Zidovudine (metabolism is decreased leading to increased plasma levels of zidovudine. Symptoms of zidovudine toxicity can be misinterpreted as opioid withdrawal

Answer 10

Cautious dose initiation with methadone is essential. Supervision of dispensed medication is needed, together with regular monitoring and review with appropriate adjustment of dosage at induction. Clinicians should explain clearly that it takes time to complete induction on to methadone and that patients will experience increasing effects from methadone over the first few days of treatment even if the dose is not increased In most heroin dependent individuals - 20-50mg prevents withdrawal symptoms and >60-80mg to block effects of additional heroin use In non-tolerant/opiate naïve people- 1 dose of 20mg can kill a child, repeated doses 30-40mg can kill an adult and 1 dose 70mg can kill an adult

Answer 11

Slow induction to avoid methadone toxicity (‘start low and go slow’) Induction: commence 20-30 mg initial dose for moderate tolerance Always less than 20 mg: if low/uncertain tolerance or other risk factors NEVER use greater than 30 mg methadone on first dose Only increase dose after reviewing patient - do not write instruction for increasing doses at pharmacy at induction Increase by 5-10 mg every 3-4 days as required Beware of ‘overshooting’ as steady-state after 3-5 days after dose change Do not increase by more than 20 mg in any one week - Remember "start low and go slow" Maximum dose of 40mg by day 7 Usually takes 2 – 6 weeks to reach maintenance dose

Answer 12

How much is the correct dose? The correct dose is as much as required to: stop withdrawal symptoms achieve treatment goals (stop heroin use) avoid side effects (of too little / too much medication) retain the patient in treatment. Most patients need 60-100 mg methadone

Answer 13

Withdrawal severity greatest in 1-2 weeks after stopping opioids Strategy to withdraw from methadone: reduce dose slowly, review frequently and reassess e.g. 2.5 - 5 mg methadone every 2 - 4 weeks If patient is experiencing severe cravings / withdrawals: cease reductions and generally increase dose If patient experiences a lapse: cease reductions and increase dose

Answer 14

The conversion between opioids and methadone is a complicated process. It is difficult to estimate conversions and varies with dose of morphine and patient variations in pharmacokinetics72, 110 e.g.72 10mg oral methadone ~30-60mg oral morphine equivalent 100mg oral methadone ~900-1200mg oral morphine equivalent Transferring from buprenorphine to methadone Stop buprenorphine daily dose Commence methadone following day per usual induction procedures 20-30mg initial dose Ensure regular reviews Increase methadone doses every 3-5 days until stable

Answer 15

1. Bivudal weekly-> time to peak plasma concentration 24 hours Subcutaneous (SC) injections in prefilled syringes with 23-gauge needle. Administration – upper arm, thigh, abdomen or buttock. Once injected the formulation transforms from liquid to highly viscous liquid crystal (gel-like). Current pricing ~$330/ month (cost covered by Medicare under S100) Available in: 8mg/0.16ml. 16mg/0.32ml. 24mg/0.48ml. 32mg/0.64ml. ``` 2. Bivudal monthly-> time to peak plasma concentration 6-10 hours Available in 64mg/0.18 ml. 96mg/0.27 ml. 128mg/0.36 ml. ``` 3. Sublocade monthly time to peak plasma concentration 24 hours Available in 100mg/0.5ml. 300mg/1.5ml. Dosing regimens 300mg monthly. 300mg for 2 months loading then 100mg thereafter.

Answer 16

The dosages of LAI BPN accumulate over time with a steady state achieved after three to six doses Bivudal weekly-> 1 month Bivudal monthly-> 4 months Sublocade 300/300 regimen-> 6 months Sublocade 300/100 regimen-> 2 months (post 300mg loading dose)

Answer 17

Bivdal weekly-> < 3 weeks Bivudal monthly-> up to 12 weeks Sublocade 100mg -> up to 12 weeks Sublocade 300mg -> up to 12 weeks

Answer 18

Patients may not be suitable for LAI BPN treatment if: 1. They prefer methadone 2. They are on QOTP as a harm reduction strategy, but self-cease intermittently to use opioid medication recreationally (and they do not wish to stop this practice) 3. .They don’t like injections 4. They are planning to become pregnant 5. LAI BPN is not suitable for people who need daily supervision due to use of concomitant drug or alcohol use where daily contact with a health professional is an important part of their careplan. It is advisable that patients / clients be both agreeable and able to attend weekly or monthly scheduled appointments due to medication ordering and storage requirements.

Answer 19

1. Buvidal® Weekly or Buvidal® Monthly should not be given to anyone hypersensitive to any of the excipients [phosphatidyl choline [soybean], glyceryl dioleate and ethanol anhydrous (in Buvidal® Weekly), and N-Methylpyrrolidone (in Buvidal® Monthly) 2. Sublocade® should not be administered to clients who have been shown to be hypersensitive to any component of the ATRIGEL® delivery system.111 (N-Methylpyrrolidone) and PLGH (poly(DL-lactide-co-glycolide) 3. Caution in those with liver disease (Child Pugh class B or C not candidates.) If mild +in LFT, prior to commencing LAI, monitor LFT on SL to ensure doesn't worsen hepatic funstion. Low initial dose LAI and regular monitoring 4. and arrythmia-> generally avoid in pts with history of prolonged QTc, caution in those using substances or taking medications that may prolong Risk benefit analysis 5. Other cautions: Orthostatic hypotension, poor respiratory function, elevation of CSF pressure, cholestasis, acute abdominal conditions, adrenal insufficiency, poor respiratory function

Answer 20

Clients should be cautioned about driving or operating hazardous machinery until the prescriber and client are satisfied that the LAI BPN does not adversely affect their ability to perform these activities

Answer 21

1. You need to ensure that a stop dose is communicated to the dosing pharmacy 2. Ensure that no takeaway doses are held by the consumer prior to the first injection date 3. That the consumer has no outstanding pharmacy debts 4. Ensure that the client carries an alert card in their wallet in case of emergency

Answer 22

A practitioner must inform the Monitored Medicines Unit of a treatment type amendment before writing a prescription for LAI BPN

Answer 23

Prescriber details (name, prescriber number, place of usual practice, phone number and specialist qualifications (if applicable)). Date of prescription. Date for supplying the medication (if applicable). Patient's details (name, address, date of birth). Name of buprenorphine product – including name and strength of product (e.g. Buvidal® Weekly 16mg; Sublocade® 100mg); and the dose (in numbers and words). Route of administration. Instructions about using the medicine

Answer 24

It is recommended that patients commencing from other opioid use (including methadone) be initiated for a short period (≥7 days) on SL BPN (as Subutex® or Suboxone®). Note for transferring from methadone, patients must be on <40mg/8ml for at least one week prior to transfer to buprenorphine. From SL BPN: currently being treated with SL BPN preparations can be transferred directly onto Buvidal® Weekly and Buvidal® Monthly one day after the last SL dose Individual clinical titration of doses may be required on subsequent doses due to the dose effect of LAI which is likely to increase with BPN accumulation until steady state equilibrium is reached (after 3-5 doses) From Bivdal weekly to monthly: Use dose equivalency when transferring from Buvidal® Weekly to Buvidal® Monthly. NB: Titration may be required even if previously stable on weekly preparations.

Answer 25

If there are signs of opioid withdrawal, cravings or persistent unsanctioned opioid use, supplemental doses may be given in the interim until the next scheduled injection Supplemental doses must be: >24 hours after a Buvidal® dose (either regular dose or supplemental dose) 8mg Buvidal® Weekly injections Doses may be given throughout the dosing period to a maximum of: 32mg for weekly injections (Buvidal® Weekly) 128mg for monthly injections (Buvidal® Monthly) If supplemental doses are required, it is preferred that 8mg Buvidal® Weekly injections are used. However, in the event of unavailability of 8mg Buvidal® Weekly preparations, low dose SL BPN (eg. 4mg or 8mg) may be used. Supplemental doses may also be required due to delayed or interrupted LAI BPN dosing, drug-drug interactions (from a new or short-term medication), or in response to other stressors or deterioration in psychological wellbeing. Note: if using SL BPN, clients should not be maintained on this for more than 14 days in addition to LAI BPN. In this case, adjustment of the Buvidal® dose is recommended. If supplemental SL BPN is required, this is to be recorded on a written instruction and submitted to the Monitored Medication Unit (MMU) following dispensing / administration.

Answer 26

Wherever possible patients/clients should reduce the LAI BPN dose prior to discontinuing dosing: For clients on Buvidal® Weekly, reducing to the 8mg weekly dose before ceasing LAI BPN For clients on Buvidal® Monthly, reducing to the 64mg dose before ceasing LAI BPN Client treatment plans should be reviewed regularly with additional psychosocial support provided (for cravings, withdrawal and relapse prevention). Symptomatic medication may be used for features of opioid withdrawal if required, however caution should be used with extended use (beyond a few days) of sedatives or hypnotic medications.25, 69 Patients/clients who have withdrawn from LAI BPN should be strongly encouraged to access supplies of take home naloxone

Answer 27

No real data, this should be avoided. | If required T/F weekly/monthly to Sublocade 100mg, if not enough go to 300mg

Answer 28

Initiate SL BPN dosing at the time of the next scheduled injection (5-9 days after Buvidal® Weekly, or 3-5 weeks after last Buvidal® Monthly injections). Dose conversion tables should be used to guide the initial SL BPN dose, with frequent clinical review in order to titrate the SL dose over subsequent days.

Answer 29

Transfer to SL BPN: Transfer of Buvidal® Weekly to methadone – transfer post stabilisation on SL BPN for at least 2 weeks. Transfer of Buvidal® Monthly to methadone – transfer post stabilisation on SL BPN for at least 4 weeks. Post stabilisation period - commence methadone at low doses (20-30mg) and titrate accordingly.

Answer 30

Consult with a Medical Addiction Specialist or ADCAS on 1800 290 928. Recommence low dose methadone (e.g. 20mg oral daily dose) at the time of the next proposed LAI dose (7 days post Buvidal® Weekly or 28 days post Buvidal® Monthly). Carefully increase the dose by no more than 5mg intervals after clinical reviews until both the methadone dose and the patient/client have stabilised. Note: BPN from LAI BPN may be present for 2-3 months after Buvidal® Monthly treatment.

Answer 31

Commencing from SL BPN preparations (Subutex® or Suboxone Patients may be directly transferred from SL BPN preparations the following day post last SL dose (however, in the event that the SL BPN has been administered, the Sublocade® dose does not need to be delayed. Initial ‘Loading’ Dose Commencing dose is 300mg for two months (as loading doses). Where there are safety concerns arising from concomitant conditions or drug-drug interactions, a patient may be commenced on 100mg. Note: even 100mg Sublocade® can significantly increase the plasma concentration of BPN. The decision to use 100mg must be discussed with the patient, documented and have treatment effects regularly monitored and doses adjusted accordingly Maintenance For most patients 100mg monthly Sublocade® doses will be adequate, maintaining plasma levels (at steady state equilibrium) achieved with the first two 300mg Sublocade® doses. 100mg maintenance doses are likely to be associated with fewer concerns regarding high dose BPN-related adverse events. 300mg maintenance doses may be required for patients previously stabilised on high dose SL BPN (24-32mg), or for patients who have experienced cravings or unsanctioned opioid use during the first two-month period of Sublocade® dosing.

Answer 32

Whilst generally not required, supplemental doses may be required during the titration phase, or due to delayed or interrupted LAI dosing, drug-drug interactions (from a new or short-term medication), or in response to other stressors or deterioration in psychological wellbeing. In these cases short term (up to 14 days) supplementary doses of SL BPN (either Subutex® or Suboxone®) of no more than 8mg daily may be prescribed as “rescue doses” until next scheduled dose of Sublocade® dosing. If supplemental doses are required, consider adjustment of the subsequent Sublocade® dose. If supplemental SL BPN is required, this is to be recorded on a written instruction and submitted to MMU following dispensing/ administration.

Answer 33

1. Testing tolerance If >56 days post last Sublocade® injection, tolerance may be tested using a dose of SL BPN (e.g 8mg), and if there are no concerns (e.g. sedation), Sublocade® may be recommenced on the previous 100mg or 300mg dose the following day. 2. Reintroduction A patient/client who has had no documented and confirmed BPN doses for >56 days since their last Sublocade® injection, or has had regular use of heroin or other opioids since last Sublocade® dose (with attendant risk of precipitated withdrawal on recommencing BPN treatment) should be re-initiated to treatment with SL BPN for ≥ 7 days prior to recommencing Sublocade® treatment.

Answer 34

Successful withdrawal from opioid treatment programs are more likely in patients/clients who: Have stopped using illicit or non-prescribed opioids; Do not have other significant substance use problems; Have been able to make lifestyle changes to support ongoing cessation of opioid use (e.g. employment, education, supportive relationships); and Who undertake planned and gradual rather than precipitous reduction regimens. Principles of withdrawing Sublocade® Wherever possible, patients/clients should reduce Sublocade® to 100mg dose before ceasing LAI BPN Treatment plans should be reviewed regularly with additional psychosocial support provided (for cravings, withdrawal and relapse prevention). Symptomatic medication may be used for features of opioid withdrawal if required, however caution should be used with extended use (beyond a few days) of sedatives or hypnotic medications25, 69 Patients/clients who have withdrawn from LAI BPN should be strongly encouraged to access supplies of take home naloxone.

Answer 35

Initiate 8mg S/L BPN four weeks after last Sublocade® dose and titrate upwards over subsequent days or weeks according to clinical need (features of withdrawal, craving, intoxication, use of unsanctioned drugs). Frequent clinical reviews are recommended during this period.

Answer 36

Sublocade® stabilisation phase 100mg dose= Bivudal monthly 96mg, Bivudal weekly 24mg, Daily SL 12-16mg Sublocade® stabilisation phase 300mg dose= Bivudal monthly 128mg, Bivudal weekly 32mg, Daily SL 12-16mg

Answer 37

– Transfer to methadone post stabilisation on SL BPN for at least 4 weeks. Post `stabilisation, commence methadone at low doses (20-30mg) and titrate accordingly.

Answer 38

1. Details of service providers prescribing and administering LAI BPN injections and previous injection sites (in order to avoid injecting into same site). 2. Dose and date of recent LAI BPN ensuring details of last dose administered are included. 3. The formulation of LAI BPN that was administered: Buvidal® Weekly, Buvidal® Monthly or Sublocade® and the dose (in mg). 4. Scheduled next dose of LAI BPN (formulation, date, dose strength and route of administration). 5. Any adverse events, risks or concerns regarding LAI BPN treatment that are relevant to other health care providers.

Answer 39

Due to the prolonged peak plasma and clinical effects from LAI BPN there is little clinical indication to withhold LAI BPN. Note: prior to administration of LAI BPN to an intoxicated patient, they must be able to be assessed as having capacity to provide informed consent to their usual dose, and to understand warnings regarding sedation and overdose from poly substance use. If this unable to occur, then the dose may be rescheduled. Patients/clients with ongoing poly substance use and intoxication should have interventions to address this. This may require more intensive monitoring and a medication option that requires more frequent dosing intervals should be considered.

Answer 40

Persistent pain management approaches should be followed and include: Patient/client education and engagement. Physical therapy (e.g. exercise, physiotherapy). Psychosocial interventions (e.g. Cognitive Behavioural Therapy, mindfulness, and pacing). Appropriate use of non-opioid medications (e.g. antidepressants, NSAIDs, paracetamol). The changes to persistent pain management approaches due to LAI BPN include: A patient should not be concomitantly prescribed opioid medications. Caution should be used in prescribing other sedative medications, particularly benzodiazpeines, Z-drugs and gabapentinoids which have been linked to increased mortality in OTP patients.

Answer 41

Mild acute pain that requires NSAIDs, paracetamol or physical therapies may be managed with these interventions. Strategies that may be employed for severe acute pain (e.g. in acute/emergency situations such as trauma, renal stones) include 25, h9 1. Use of higher doses of traditional opioids such as morphine (with careful titration of effects); 2. Use of mu opioid receptor super agonists such as fentanyl that themselves have similar or higher mu intrinsic activity than BPN; 3. Use of parenteral BPN (e.g. Temgesic®) for breakthrough pain; 4. Non-opioid analgesic approaches such as ketamine infusions or regional analgesia.

Answer 42

There is a lack of research data on the safety and efficacy of LAI BPN during pregnancy. Three areas of difference between LAI BPN and SL BPN that may impact pregnancy and should be considered are: The higher and more stable maternal blood levels of BPN. The excipients in Buvidal® Weekly, Buvidal® Monthly and Sublocade®. Specifically, N-Methylpyrrolidone (NMP) is an excipient in Buvidal® Monthly and Sublocade®. There is potential for NMP to cause harm although it is below Australian thresholds for inclusion in product warnings. There is some evidence of toxicity in animal studies. Pregnancy is listed as a contraindication to Buvidal® Weekly and Buvidal® Monthly in the Australian Product Information,112 and as a warning and precaution in Sublocade®.113 Pregnant women on LAI BPN may be transferred to SL BPN. There may be clinical situations where pregnant women may not easily transfer to SL BPN (e.g. lack of access to daily sublingual treatment dosing) or it may be considered that a pregnant woman is more likely to remain stable on LAI BPN rather than transferring to sublingual treatment (i.e. the risks of transfer to sublingual treatment may outweigh the expected benefits).2 LAI BPN should only be used during pregnancy if the potential benefit justifies the potential risks to the mother and baby.2 Pregnancy Statement Checklist for initiating LAI BPN on pregnant women.

Answer 43

There is no data on the onset, severity and time course of Neonatal Opiate Withdrawal Syndrome (NOWS) also known as Neonatal Abstinence Syndrome (NAS) for long-acting preparations.111 Liaison with neonatologists/specialist paediatricians should occur regarding screening and treatment for NOWS for neonates exposed to long-acting injection preparations during pregnancy

Answer 44

Breastfeeding is listed as a contraindication to Buvidal® Weekly and Buvidal® Monthly Although not recommended in the product information, long-acting preparations may be used if the potential benefits outweighs the potential risks to mother and baby.111 Situations include lack of access to daily sublingual treatment or the breastfeeding woman is more likely to remain stable on long-acting preparations

Answer 45

If LAI Sublocade® must be removed it can be surgically excised under local anaesthetic within 14 days of injection. Procedure of removal Place a small incision in the abdomen where the LAI was placed. Remove the LAI with forceps and suturing to close the incision. The removed LAI should then be handled in accordance with Queensland legislation relating to scheduled medicines. Patients should be monitored for withdrawal and treated as required.

Answer 46

All patients/clients must be registered on the Queensland Opioid Treatment Program (QOTP) when commencing LAI BPN. When transferring from the SL BPN to LAI BPN a new admission form noting the change of drug type to LAI BPN is required to be submitted to the Monitored Medicines Unit (MMU) Documentation The prescriber must document in the patient's clinical record each time they prescribe and administer the LAI BPN. The documentation should include the following particulars: Prescriber's name, prescriber number, phone number, specialist qualifications (if applicable). Patient/clients name and date of birth. Date of prescribing and date of administration. Drug name (including the brand name), dose, route of administration. Site of administration. Instructions about using the medicine.

Answer 47

Advantages Minimises diversion to others Minimises misuse of medication (e.g. injecting) Greater medication adherence Daily contact with services for better supervision of treatment Disadvantages Inconvenience to patients & staff Cost to patients / health services Barrier to community integration Stigma and discrimination

Answer 48

Continued drug use: opioids, benzodiazepines, alcohol, amphetamines, cannabis etc. which is self-reported &/or objective measures (urine drug screen) Recently commenced on program (< 3 months) or unstable on treatment or adjusting dose Poor adherence to appointments & dosing requirements Risk to safety of take-away doses (safe storage, history of abuse, vulnerable/being stood over) Medical / psychiatric / social (& child safety) conditions

Answer 49

Methadone: No TADs (except in special circumstances) under three months on program, then increased incrementally up to maximum 4 TADs per week Subutex®: 0-4 TADs per week (increased incrementally) for pregnant, breastfeeding, or allergic to naloxone and assessed as suitable Suboxone® (BUP/NAL): No TADs in the first 1 to 3 months of treatment (except in special circumstances i.e. pregnant/breastfeeding), then up to maximum 31 TADs per month increased incrementally.

Answer 50

Opioid dependence is a relapsing and chronic condition that requires good therapeutic alliance to retain the patient in treatment a partnership approach to addressing substance use should be fostered. Substance use may be disclosed by clients and should be systematically addressed in clinical reviews. Urine drug screen and breath alcohol level (BAL) monitoring can also identify undisclosed substance use In the case of continued drug use: Review treatment - if using opioids and not intoxicated, dose increases may be indicated Assess drug use, risk behaviours, medical, psychiatric, social circumstances Re-examine patient treatment goals Increase frequency of reviews and monitoring (urine drug screens) Adjust medication regimes e.g. split doses for evening pain Review safety for take-away doses Provide evidence-based psychosocial interventions and supports for poly-substance use

Answer 51

``` Sedation, ‘nodding off’ Respiratory depression Pin point pupils (‘pinned’) Nausea and vomiting Itching Bradycardia Hypotension ```

Answer 52

``` Dishevelled appearance Disinhibited, irrational or aggressive behaviour Sedated Impaired coordination and ataxia 148 Slurred speech Slow pupil reaction ```

Answer 53

Around 60% of clients on methadone in OTP have persistent pain, and similarly, at least 33% of clients on buprenorphine or buprenorphine/naloxone also have persistent pain. While for many with persistent pain, a biomedical ‘cure’ may not be achievable, a reduction in pain and improved function can be achieved with active self-management Pharmacologically, methadone and buprenorphine both provide effective analgesic properties. There is now good evidence that treatment of opioid dependence, whether arising from street heroin or prescription opioids, with opioid substitution treatment is generally effective for pain management When prioritising management of opioid dependence, and considering pain, reassure the client their OTP medication is a strong opioid which will provide analgesia while also treating dependence. For clients with continuing pain it is important to perform a comprehensive pain assessment, make a risk assessment for an opioid trial, use universal precautions and include regular monitoring and assessment- referring to pain management services as required.

Answer 54

Severe side effects of opioid treatment which may affect treatment plans can include: Cardiac arrhythmias due to the prolongation of the QTc interval renders methadone treatment unsuitable in some patients. Care should be taken in persons with a personal or family history of long QT syndrome, arrhythmias, heart disease, and electrolyte depletion (hypokalemia and hypomagnesemia), or those on cardiac medications affecting repolarisation Altered pharmacokinetics may be result of genetic differences in cytochrome enzymes and produce variability in experience and tolerance. Sexual health - fertility (sperm motility and volume depression), as well as impotence, delayed or failed ejaculation may be significant concerns for male patients on methadone. Whilst mild asthma and emphysema are not contraindications to treatment it is appropriate to review other factors that may contribute to respiratory distress. Severe compromise in respiratory function is a contraindication to therapy should have specialist input. Severe liver and renal disease - can result in dose accumulation resulting from slow metabolism and delayed elimination, and dose adjustments may need to be considered. Metabolic health conditions: there is contradictory evidence about the effects of OTP (particularly methadone) and its effects on thyroid function. As a general rule, care should be taken in prescribing for patients with uncorrected endocrine abnormalities including hypothyroidism and adrenocortical insufficiencies. There is limited evidence about glycaemic control and use of OTP. Existing evidence indicates that there is a higher rate of type II diabetes in those receiving methadone than the general population161, but better glycaemic control for those with type II diabetes on buprenorphine replacement. Caution should be taken when prescribing for those with diabetes, with ongoing glycaemic monitoring and specialist input if required. Hepatitis C -Over 50% of clients entering OTP have chronic hepatitis C (CHC) infection. 25 Caution with hepatic impairment and dose adjustments. Caution should also be taken with Hepatitis C treatment drug interactions although there is no evidence of drug interactions between direct-acting antiviral therapies and OTP. 25 The University of Liverpool's Hepatitis Medication Checker is an excellent resource. HIV - Clients who are HIV-positive should, if possible, be managed in collaboration with specialist services and community-based support services.25 These clients may have a range of medical conditions and assessment/management of possible drug interactions between OTP pharmacotherapy and other medications is necessary.The University of Liverpool's HIV Medication Checker is an excellent resource. Ageing clients - There is limited evidence about opioid replacement regimes for older adults.Older people who use drugs are likely to metabolise drugs at a slower rate, making lower opioid doses and slower dose titration of methadone advisable in older clients. Consideration to cognitive impairment and risk should be undertaken. Special advice may be required to be given to nursing home and staff who may be unfamiliar with OTP.

Answer 55

Withdrawal from opioids is considered to be a higher risk than opioid replacement therapy during pregnancy. This is due to the risk of relapse and exposure of the woman and fetus to unsanctioned drug use, with opioid replacement therapy showing better outcomes. Although there is limited evidence in literature it is also generally accepted that if withdrawal were to take place, it is inadvisable during the first trimester (due to risk of miscarriage) and third trimester (due to risk of preterm birth)

Answer 56

With a growing evidence base of effectiveness,171 ORT treatment with buprenorphine-mono or buprenorphine/naloxone is now considered standard care in pregnancy. While methadone has historically been the ‘the gold standard’ for ORT in pregnancy and continues to be an accepted treatment option, it is no longer necessary to favour methadone when treating pregnant women. focus for the prescriber and patient should be to achieve stability, reduce other substance use including smoking, and increase engagement in regular antenatal care. Current practice with pregnant women on ORT, should be the continuation on the mother's current regimen, unless otherwise clinically indicated.

Answer 57

With physiological changes during third trimester in particular, around metabolic needs and placenta absorption, dose increases are often needed; split (twice daily) dosing may be required, particularly with methadone, to provide stable 24 hour coverage. The involvement of a Drug and Alcohol Specialist should always be sought in planning treatment for pregnant opioid-dependent women. Liaison with CHAMPS (Mater Hosp, Brisbane), or Lotus (RBWH) clinics, or your local equivalent specialist ante-natal service, as per MATOD Guidelines, is advised

Answer 58

For mothers who are stable on ORT breastfeeding should be supported and may help to decrease the severity of Neonatal Abstinence Syndrome (NAS). Mothers who are unstable, continuing to use illicit opioids or multiple drugs, breastfeeding should not be recommended.

Answer 59

Babies whose mothers have been opioid dependent in pregnancy should be monitored from birth for NAS using the Finnegan’s scoring system. An extended postnatal stay is recommended for at least 5 days

Answer 60

Signs and symptoms of NAS include continuous crying, irritability, tremors, excessive sucking, vomiting/diarrhoea, increased temperature, sweating and seizures. NAS cannot be predicted based on maternal dosage and mothers should be reassured that even if they are on a high dose of ORT, their baby may not necessarily suffer from NAS Other factors may contribute to the severity of NAS including maternal smoking and poly drug use

Answer 61

Approval to treat drug dependent persons with methadone or buprenorphine must be obtained prior to commencing treatment from the Director- General, Qld Health via the Delegate of the Chief Executive ie. Director of Monitored Medication's Unit (previously DDU and MMU) [Section 122] Approval is renewed every five years and must be applied for using the approved form Each patient must be admitted onto the QOTP using an admission form with Monitored Medications Unit, prior to the first dose Each patient may have only one prescriber Each prescriber should nominate a back-up prescriber who will have authority to write unchanged scripts during periods of leave etc. It is essential that this person is approved, willing and understands their regulatory requirements. At the end of treatment, the doctor should complete a discharge form and provide to the Monitored Medicines Unit. Treatment with any other S8 drugs (physeptone) or S4 drugs (benzodiazepines) requires individual patient approvals before prescribing to persons identified to be drug dependent.

Answer 62

implementation of coordinated care systems and processes within primary care improve access and is an effective treatment strategy to improve results for patients receiving medication - assisted treatment for opioid use disorder Can be resource intensive An alternative which may be suitable for complex clients, or GPs not wanting to take on full authority to prescribe 1. Client diagnosed opioid dependent 2. Referred to QOTP via QLD health ATODS 3. Stabilised on QOTP by addiction Specialist 4. Referred back to GP to manage monthly Written instruction 5. 3 monthly review with GP and OTP clinic 6. Annual review with OTP clinic

Answer 63

Reduces stigma Enhance client autonomy Increased capacity for improving health outcomes for client

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